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

Model Number	03.120.005
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient id= (b)(6).Initial reporter synthes employee.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing 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
Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that periarticular aiming arm can not be fixed on the insertion handle.It was not reported that there was any surgical delay.There was no patient consequence.Concomitant device reported: unknown periarticular aiming arm (part # unknown, lot # unknown, quantity unknown).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.H3, h6: a product investigation was conducted.Visual inspection: the insertion handle f/aiming arm f/lcp prox (part # 03.120.005/ lot # 3094728) was received at us cq.Upon magnification, it was identified that the most proximal internal threads where the insertion handle would mate with the aiming arm were stripped/deformed.Due to the stripped/deformed condition of the internal threads, the insertion handle would not be able to mate with a relevant aiming arm.The overall complaint was confirmed due to the identified damage.Dimensional inspection: dimensional inspection was performed due to post manufacturing damage.Document/specification review: drawing(s) reviewed: (current & manufactured revisions) conclusion: the overall complaint was confirmed for the received the insertion handle f/aiming arm f/lcp prox as the internal threads were stripped/deformed.Although no definitive root-cause can be determined its possible the device experienced unintended forces while in use, damaging the threads.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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.H3, h4, h6: a device history record (dhr) review was conducted: part: 03.120.005, lot: 3094728, manufacturing site: haegendorf, release to warehouse date: 18.Mar.2009.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.

• Brand Name: PERIARTICULAR INSERTION HANDLE FOR 4.5MM LCP PROX TIBIA PL-LT
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9539808
• Report Number: 2939274-2020-00019
• Device Sequence Number: 19416931
• Product Code: FZX
• UDI-Device Identifier: 10886982074034
• UDI-Public: (01)10886982074034
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.120.005
• Device Catalogue Number: 03.120.005
• Device Lot Number: 3094728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Initial Date Received by Manufacturer: 12/08/2019
• Supplement Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 01/02/2020
• Supplement Report FDA Received Date: 02/10/2020
• 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