NORIAN DRILLABLE INJECT 5CC-STERILE
Report
- Report Number
- 2939274-2021-03261
- Event Type
- Malfunction
- Date Received
- June 28, 2021
- Report Date
- June 1, 2021
- Manufacturer
- WRIGHTS LANE SYNTHES USA PRODUCTS LLC
- Product Code
- MQV
- UDI-DI
- 10886982131614
- PMA / PMN Number
- K102722
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: H6 - CODES UPDATED TO IMDRF CODES. VISUAL INSPECTION: THE NORIAN DRILLABLE INJECT 5CC-STERILE (PART# 07.704.005S, LOT# DS7006680) WAS RETURNED AND RECEIVED AT DSM BIOMEDICAL. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE MATERIAL IN THE POUCH HAD HARDENED INDICATING THAT SOME OF THE SOLUTION HAD BEEN SUCCESSFULLY INJECTED AND A REACTION HAD OCCURRED. THE CRACK ALONG THE LENGTH OF THE LUER LOCK WAS VISIBLE AFTER CLOSE INSPECTION. NO OTHER ISSUES WERE OBSERVED WITH THE RETURNED DEVICE. FUNCTIONAL TEST: A FUNCTIONAL TEST WAS NOT PERFORMED AS IT WAS OBSERVED THAT THE LUER LOCK WAS CRACKED THUS CONFIRMING THE COMPLAINT CONDITION. CAN THE COMPLAINT BE REPLICATED WITH THE RETURNED DEVICE- YES, VISUAL OBSERVATION OF THE DEVICE CONFIRMED THE LUER LOCK TO HAVE BEEN CRACKED LEADING TO THE NON-FUNCTIONALITY OF THE DEVICE. DIMENSIONAL INSPECTION: NO DIMENSIONAL INSPECTION CAN BE PERFORMED DUE TO POST-MANUFACTURING DAMAGE. DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND MANUFACTURED REVISION OF DRAWINGS WERE REVIEWED. INVESTIGATION CONCLUSION: THE COMPLAINT CONDITION WAS CONFIRMED FOR THE NORIAN DRILLABLE INJECT 5CC-STERILE (PART# 07.704.005S, LOT# DS7006680) AS THE LUER LOCK WAS CRACKED LEADING TO THE LEAKAGE OF THE CEMENT WHILE INJECTING. THE ROOT CAUSE FOR THE REPORTED ISSUE IS ATTRIBUTED TO A MANUFACTURING RELATED ISSUE. NR-0173166 WAS INITIATED TO TRACK FURTHER INVESTIGATION OF THIS PRODUCT FAILURE. 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 - PART # 07.704.005S. SYNTHES LOT # DS7006680. SUPPLIER LOT # DS7006680. RELEASE TO WAREHOUSE DATE: 29 MAR 2021. EXPIRATION DATE: 28 DEC 2022. SUPPLIER: (B)(4). NO NCR'S WERE GENERATED DURING PRODUCTION. DEVICE HISTORY REVIEW - REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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.
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. D9, H3, H6: THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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.
COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. REPORTER IS A J&J SALES REPRESENTATIVE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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.
IT WAS REPORTED THAT, NORIAN WAS MIXED IN THE NORMAL FASHION. WHEN THE NORIAN POUCH WAS PLACED IN THE ROLLERS TO TRANSFER INTO THE SYRINGE, NOTHING CAME OUT. A NEW BOX OF NORIAN WAS OPENED AND MIXED IN THE SAME WAY WITH NO ISSUES. THEY CONCLUDED THAT THE ISSUE COULD NOT HAVE BEEN WITH MIXER UNIT. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH (3) MINUTES OF SURGICAL DELAY. NO FRAGMENTS WERE GENERATED AND NO PATIENT CONSEQUENCE. THIS REPORT IS FOR (1) NORIAN DRILLABLE INJECT 5CC-STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 974203 | NORIAN DRILLABLE INJECT 5CC-STERILE | FILLER, CALCIUM SULFATE PREFORMED PELLETS | MQV | WRIGHTS LANE SYNTHES USA PRODUCTS LLC | 07.704.005S | DS7006680 | 10886982131614 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Female | UNK - MIXERS: TRAUMA| UNK - MIXERS: TRAUMA |