EXPEDIUM VERSE SPINE SYSTEM VERSE CORRECTION KEY 5.5

Report

Report Number: 1526439-2020-00711
Event Type: Malfunction
Date Received: March 13, 2020
Date of Event: February 5, 2020
Report Date: February 17, 2020
Manufacturer: MEDOS INTERNATIONAL SÃ RL CH
Product Code: KWQ
UDI-DI: 10705034466132
PMA / PMN Number: PRE-AMEND
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SZ
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H3, H6: INVESTIGATION SUMMARY BACKGROUND: 03/23/2020 UPDATED EVENT DESCRIPTION: SEVERAL EXPEDIUM VERSE DUAL INNIES BROKE INTRAOPERATIVELY IN A COMPLEX SKOLIOSIS CASE. IMPLANTS ARE AVAILABLE FOR INVESTIGATION. CUSTOMER/SURGEON CLAIMS THAT IMPROPER HANDLING CAN BE EXCLUDED. OUTER RING OF DUAL INNIE BROKE WHILE FINAL TIGHTENING. BROKEN DUAL INNIES ALSO DESTROYED THE THREAD OF THE IMPLANTED SCREWS. THE POLYAXIAL MECHANISMS OF ANOTHER SCREW'S HEAD BLOCKED AND NEEDED TO BE REPLACED (IMPLANT IS AVAILABLE FOR INVESTIGATION). CUSTOMER ALSO REPORTED BREAKAGE OF DUAL INNIES IN OTHER CASES - NO IMPLANTS AVAILABLE FOR INVESTIGATION. CONCOMITANT DEVICE REPORTED: VERSE CORRECTION KEY (PART# 199721000, LOT# 258763, QUANTITY 6). VERSE CORRECTION KEY (PART# 199721000, LOT# 225038, QUANTITY 2). VERSE CORRECTION KEY (PART# 199721000, LOT# 245738, QUANTITY 2). VERSE CORRECTION KEY (PART# 199721000, LOT# 254143, QUANTITY 2). VERSE CORRECTION KEY (PART# 199721000, LOT# 251759, QUANTITY 1). VERSE CORRECTION KEY (PART# 199721000, LOT# 229652, QUANTITY 1). VERSE CORRECTION KEY (PART# 199721000, LOT# 237145, QUANTITY 1). THIS COMPLAINT INVOLVES NINETEEN (19) NUMBER OF DEVICES. INVESTIGATION FLOW: DAMAGE. VISUAL INSPECTION: VERSE CORRECTION KEY WAS RECEIVED AT US CQ. UPON VISUAL INSPECTION AT CQ, IT IS OBSERVED THAT EXTERNAL THREADS OF THE POLY LOCK GOT PEELED OFF AND THERE WERE SEVERE SCRATCHES ON THE SURFACE OF THE POLY LOCK. THE ROD LOCK WAS ALSO SEVERELY DEFORMED AND GOT STUCK IN THE POLY LOCK HALFWAY. THUS, THE COMPLAINT IS BEING CONFIRMED. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION OF THE RECEIVED COMPLAINT DEVICE CANNOT BE PERFORMED AT CQ DUE TO POST MANUFACTURING DAMAGE. DOCUMENTATION/ SPECIFICATION REVIEW: THE FOLLOWING DRAWING(S) WAS REVIEWED; EXPEDIUM VERSE DUAL LOCK ASSEMBLY: DWG-887010006 REV. D AND REV. E. NO DESIGN ISSUES OR DISCREPANCIES WERE FOUND DURING THIS INVESTIGATION. INVESTIGATION CONCLUSION: VISUAL INSPECTION, AND DOCUMENT SPECIFICATION REVIEW OF THE RECEIVED DEVICE WAS PERFORMED AT CQ. THE COMPLAINT IS BEING CONFIRMED AS IT IS OBSERVED THAT EXTERNAL THREADS OF THE POLY LOCK GOT PEELED OFF AND THERE WERE SEVERE SCRATCHES ON THE SURFACE OF THE POLY LOCK. WHILE A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, IT IS POSSIBLE THAT THE DEVICE MIGHT HAVE ENCOUNTERED UNINTENDED FORCES. DURING THE INVESTIGATION NO UNIDENTIFIED PRODUCT DESIGN/MANUFACTURING ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: MRE WAS NOT PERFORMED DUE TO THE ILLEGIBLE LOT NUMBER OF THE DEVICE. D11: CONCOMITANT PRODUCT UPDATED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem · 0

03/23/2020 UPDATED EVENT DESCRIPTION: SEVERAL EXPEDIUM VERSE DUAL INNIES BROKE INTRAOPERATIVELY IN A COMPLEX SKOLIOSIS CASE. IMPLANTS ARE AVAILABLE FOR INVESTIGATION. CUSTOMER/SURGEON CLAIMS THAT IMPROPER HANDLING CAN BE EXCLUDED. OUTER RING OF DUAL INNIE BROKE WHILE FINAL TIGHTENING. BROKEN DUAL INNIES ALSO DESTROYED THE THREAD OF THE IMPLANTED SCREWS. THE POLYAXIAL MECHANISMS OF ANOTHER SCREW'S HEAD BLOCKED AND NEEDED TO BE REPLACED (IMPLANT IS AVAILABLE FOR INVESTIGATION). CUSTOMER ALSO REPORTED BREAKAGE OF DUAL INNIES IN OTHER CASES - NO IMPLANTS AVAILABLE FOR INVESTIGATION. CONCOMITANT DEVICE REPORTED: VERSE CORRECTION KEY (PART# 199721000, LOT# 258763, QUANTITY 6). VERSE CORRECTION KEY (PART# 199721000, LOT# 225038, QUANTITY 2). VERSE CORRECTION KEY (PART# 199721000, LOT# 245738, QUANTITY 2). VERSE CORRECTION KEY (PART# 199721000, LOT# 254143, QUANTITY 2). VERSE CORRECTION KEY (PART# 199721000, LOT# 251759, QUANTITY 1). VERSE CORRECTION KEY (PART# 199721000, LOT# 229652, QUANTITY 1). VERSE CORRECTION KEY (PART# 199721000, LOT# 237145, QUANTITY 1). THIS COMPLAINT INVOLVES NINETEEN (19) NUMBER OF DEVICES.

Additional Manufacturer Narrative · 1

IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. INITIAL REPORTER IS SYNTHES SALES REPRESENTATIVE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem · 1

DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, SEVERAL EXPEDIUM VERSE DUAL INNIES BROKE INTRAOPERATIVELY IN A COMPLEX SKOLIOSIS CASE. THE SURGEON CLAIMS THAT "INPROPPER" HANDLING CAN BE EXCLUDED. OUTER RING OF DUAL INNIE BROKE WHILE FINAL "TIGHETENING". BROKEN DUAL INNIES ALSO DESTROYED THE THREAD OF THE IMPLANTED SCREWS. THE POLYAXIAL MECHANISMS OF ANOTHER SCREW HEAD BLOCKED AND NEEDED TO BE REPLACED. THERE WAS A SURGICAL DELAY OF THIRTY (30) MINUTES. CONCOMITANT DEVICES REPORTED: EXPEDIUM VERSE SPINE SYSTEM VERSE CORRECTION KEY 5.5 (PART#: 199721000, LOT#: UNKNOWN, QUANTITY#: 8), 5.5 EXP VERSE FEN SCR 5.0X45 (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY#: 9), UNKNOWN MONO/POLYAXIAL SCREWS (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY#: 1). THIS REPORT IS FOR ONE (1) EXPEDIUM VERSE SPINE SYSTEM VERSE CORRECTION KEY 5.5 THIS IS REPORT 7 OF 8 FOR B)(4). THIS (B)(4) CAPTURE THE 9 OUT OF 19 DEVICES REPORTED AND (B)(4) CAPTURE THE 10 OUT OF 19 DEVICES REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
294069	EXPEDIUM VERSE SPINE SYSTEM VERSE CORRECTION KEY 5.5	APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY	KWQ	MEDOS INTERNATIONAL SÃ RL CH	199721000		10705034466132

Patients

Seq	Age	Sex	Outcome	Treatment
1				5.5 EXP VERSE FEN SCR\| 5.5 EXP VERSE FEN SCR\| EXPEDIUM VERSE SPINE SYSTEM\| EXPEDIUM VERSE SPINE SYSTEM\| UNKNOWN MONO/POLYAXIAL SCREWS\| UNKNOWN MONO/POLYAXIAL SCREWS\| VERSE CORRECTION KEY\| VERSE CORRECTION KEY\| VERSE CORRECTION KEY\| VERSE CORRECTION KEY\| VERSE CORRECTION KEY\| VERSE CORRECTION KEY