MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PERIARTICULAR INSERTION HANDLE FOR 4.5MM LCP PROX TIBIA PL-R; GUIDE, SURGICAL, INSTRUMENT

Model Number	03.120.002
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Tissue Damage (2104); No Code Available (3191); Unspecified Tissue Injury (4559)
Date of Event	09/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.(b)(4).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.
Event or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 during an open reduction internal fixation (orif) for a tibial plateau, the insertion device to fix the tibial plateau was not functioning properly.The threads inside the right post seem to be damaged.The surgery was completed successfully with another technique.Concomitant device: unknown aiming arm (part # unknown, lot # unknown, quantity 1).This report is for one (1) periarticular insertion handle for 4.5mm lcp prox tibia pl-r.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
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.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.
Event or Problem Description
The surgery was completed successfully by extending the incision.
Additional Manufacturer Narrative
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, h4, h6: part 03.120.002, lot 3156784: manufacturing site: hägendorf.Release to warehouse date: june 15, 2009.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.H3, h6: a product investigation as completed: upon visual inspection, it was observed the internal threads were damaged and deformed.There were scratches/nicks were observed on the device but have no impact on the device functionality.No other issues were observed with the returned device.A functional testing and replication of the event conditions could not be performed since mating devices were not returned.The tip of the device was measured and was within the specification.Based on the date of manufacture, the current and manufactured revision of drawings were reviewed.The complaint condition was confirmed.There is no indication that a design or manufacturing issue has caused the complaint condition.The potential cause could be due to unintended forces applied to the device.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 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.

• Brand Name: PERIARTICULAR INSERTION HANDLE FOR 4.5MM LCP PROX TIBIA PL-R
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10742367
• Report Number: 2939274-2020-04839
• Device Sequence Number: 14238253
• Product Code: FZX
• UDI-Device Identifier: 10886982074003
• UDI-Public: 10886982074003
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.120.002
• Device Catalogue Number: 03.120.002
• Device Lot Number: 3156784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 12/04/2020; 12/23/2020
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 12/23/2020; 12/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - GUIDES/SLEEVES/AIMING: AIMING ARM
• Outcome Attributed to Adverse Event: Required Intervention