18.0MM REAMER HEAD FOR RIA 2 STERILE
Report
- Report Number
- 8030965-2021-00154
- Event Type
- Injury
- Date Received
- January 7, 2021
- Date of Event
- December 10, 2020
- Report Date
- December 10, 2020
- Manufacturer
- WRIGHTS LANE SYNTHES USA PRODUCTS LLC
- Product Code
- HTO
- PMA / PMN Number
- K111437
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
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. H9:FDA CORRECTION/ REMOVAL REPORTING NO.: 3008812560-10/26/2020-001-C. 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. H10 ADDITIONAL NARRATIVE: H3, H4, H6- PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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 HISTORY LOT : PART # 03.404.032S. SYNTHES LOT # 26P6726. SUPPLIER LOT # N/A. SUPPLIER BATCH #6772017. RELEASE TO WAREHOUSE DATE: 12DEC2019. EXPIRATION DATE: 01NOV2029. SUPPLIER: (B)(4). NO NCR'S WERE GENERATED DURING PRODUCTION. DEVICE HISTORY BATCH :NULL. DEVICE HISTORY REVIEW : REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, 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.
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. H10 ADDITIONAL NARRATIVE: B5: UPDATED EVENT DESCRIPTION D1, D2A, D4: UPDATED D2: ADDITIONAL PRODUCT CODE : HTO D10: UPDATED CONCOMITANT PRODUCTS G1: 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.
UPDATED EVENT DESCRIPTION. CONCOMITANT DEVICES REPORTED: REAMER HEAD F/RIA 2 Ø14.5 (PART# 03.404.025S, LOT# 38P7779 , QUANTITY# 1) REAMER HEAD F/RIA 2 Ø17 (PART# 03.404.030S, LOT# 57P0546, QUANTITY# 1) REAMER HEAD F/RIA 2 Ø15 (PART# 03.404.026S, LOT# 28P3145, QUANTITY# 1) DEPTH GAUGE F/NAILS (PART# 351.717, LOT# H497060, QUANTITY# 1) DRIVE SHAFT F/RIA 2 L520 (PART# 03.404.035, LOT# H887254, QUANTITY# 2) ELONGATION TUBE F/REAMRODS F/DEPTH GAUGE (PART# 351.719, LOT# H857290, QUANTITY# 1) SYNREAM REAMING ROD Ø2.5 SHORT L950 (PART# 352.032S, LOT# 7L09436, QUANTITY# 1) NTOC CASE FOR RIA 2 INSTRUMENT SET 2/2 (PART# 68.033.113, LOT# UNKNOWN, QUANTITY# 1) REAMER HEAD F/RIA 2 Ø17.5 (PART# 03.404.031S, LOT# 56P5873, QUANTITY# 1) REAMER HEAD F/RIA 2 Ø10.5 (PART# 03.404.017S, LOT# 45P4761, QUANTITY# 1) REAMER HEAD F/RIA 2 Ø13.5 (PART# 03.404.023S, LOT# 38P7776, QUANTITY# 1) REAMER HEAD F/RIA 2 Ø12.5 (PART# 03.404.021S, LOT# 26P6736, QUANTITY# 1) REAMER HEAD F/RIA 2 Ø11.5 (PART# 03.404.019S, LOT# 26P6731, QUANTITY# 1) REAMER HEAD F/RIA 2 Ø16 (PART# 03.404.028S, LOT# 38P4643, QUANTITY# 1) REAMER HEAD F/RIA 2 Ø15.5 (PART# 03.404.027S, LOT# 26P3634, QUANTITY# 1) REAMER HEAD F/RIA 2 Ø16.5 (PART# 03.404.029S, LOT# 38P0173, QUANTITY# 1) THIS COMPLAINT INVOLVES TEN (10) DEVICES.
510K: THIS REPORT IS FOR AN UNKNOWN REAMER HEAD II/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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.
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2020, THERE WAS A CONNECTION ISSUE BETWEEN THE SHAFT AND THE REAMER HEAD DURING THE USE OF THE REAMER / IRRIGATOR / ASPIRATOR (RIA) 2. ATTACHMENT OF THE REAMER HEAD EASILY UNCLIPPED WHEN PASSING HARD BONE (SITE OF PSEUDARTHROSIS) AND BROKE WITH FRAGMENT LOST IN THE FEMUR. THE BROKEN FRAGMENT WAS LEFT IN THE PATIENT. THE PROCEDURE WAS DELAYED FOR UNSPECIFIED AMOUNT BUT IT COULD STILL BE COMPLETED. NO FURTHER INFORMATION PROVIDED. CONCOMITANT DEVICE REPORTED: UNKNOWN RIA SHAFT(PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1) THIS REPORT IS FOR ONE (1) UNKNOWN REAMER HEAD II. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 28661 | 18.0MM REAMER HEAD FOR RIA 2 STERILE | REAMER | HTO | WRIGHTS LANE SYNTHES USA PRODUCTS LLC | 26P6726 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | DEPTH GAUGE F/NAILS| DRIVE SHAFT F/RIA 2 L520| ELONGATION TUBE F/REAMRODS F/DEPTH GAUGE| NTOC CASE FOR RIA 2 INST. SET 2/2| REAMER HEAD F/RIA 2 Ø10.5| REAMER HEAD F/RIA 2 Ø11.5| REAMER HEAD F/RIA 2 Ø12.5| REAMER HEAD F/RIA 2 Ø13.5| REAMER HEAD F/RIA 2 Ø14.5| REAMER HEAD F/RIA 2 Ø15| REAMER HEAD F/RIA 2 Ø15.5| REAMER HEAD F/RIA 2 Ø16| REAMER HEAD F/RIA 2 Ø16.5| REAMER HEAD F/RIA 2 Ø17| REAMER HEAD F/RIA 2 Ø17.5| RIA 2 BONE HARVESTING KIT L520| SYNREAM REAMING ROD Ø2.5 SHORT L950| UNK - RIA SHAFT |