MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC AIMING ARM F/3.5MM LCP LOW BND MEDIAL DISTAL TIBIA PL/RIGHT; GUIDE, SURGICAL, INSTRUMENT

Model Number	03.113.001
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation is in progress, 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
It was reported that on (b)(6) 2021 while inserting a distal tibia plate, the aiming arm was missing the proximal holes.After the case it was determined that there was an issue with the aiming arm and it is possible that the right side aiming arm was either damaged/bent.Once the problem was identified, the surgery proceeded and was successfully finished.The surgery was delayed for fifteen (15) minutes.This report is for one (1) aiming arm f/3.5mm lcp low bnd medial distal tibia pl/right.This is report 1 of 3 for complaint (b)(4).
Additional Manufacturer Narrative
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: a2: h3, h4, h6: device history lot device history lot part b38 lot 9290243 combination are unknown, as the article b38 is a semi finished part of 03.113.001, based on this we will do mre on article 03.113.001 and lot 9290243 combination.Part: 03.113.001 lot: 9290243 manufacturing site: hägendorf release to warehouse date: 10.Feb.2015 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Investigation summary: background: it was reported that on february 14, 2021 while inserting a distal tibia plate, the aiming arm was missing the proximal holes.After the case it was determined that there was an issue with the aiming arm and it is possible that the right side aiming arm was either damaged/bent.Once the problem was identified, the surgery proceeded and was successfully finished.The surgery was delayed for 15 minutes.This complaint involves three (3) devices.Investigation flow: damage / device interaction visual inspection: a arm 3.5 lcp low bnd med dstl tib pl/rt (part# 03.113.001, lot# 9290243, qty# 1) was returned and received at us cq.Upon visual inspection at cq, it is observed that the device was slightly bent.Rest of the surface of the device shows normal wear consistent with the device use which would not contribute to the complaint condition.Functional testing: complete functional testing cannot be performed at cq as all the mating devices were not returned at cq.However, the aiming arm was assembled and disassembled with the handle (03.113.025, 9872407) as intended without any issues.Unable to perform/replicated the complaint with the returned device(s).Dimensional inspection: dimensional inspection of the received device was performed at cq.The thickness of the arm was intended to be measuring from 13.5mm to 14.5mm and it was measured to be 13.89mm which is within specification.Document/specification review: drawings were reviewed during the investigation: complaint was confirmed.Investigation conclusion the complaint condition was confirmed for the a arm 3.5 lcp low bnd med dstl tib pl/rt (part# 03.113.001, lot# 9290243).While a definitive root cause cannot be determined, it is possible that the device might have encountered unintended forces.There were no issues during the manufacture of this product that would contribute to this complaint condition.During the investigation, no product design issues, or discrepancies were observed that may have contributed to the complaint condition.Based upon these results, 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.Therefore, it has been determined that no corrective and/or preventive action is proposed.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: AIMING ARM F/3.5MM LCP LOW BND MEDIAL DISTAL TIBIA PL/RIGHT
• 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: 11474882
• Report Number: 2939274-2021-01299
• Device Sequence Number: 19881013
• Product Code: FZX
• UDI-Device Identifier: 10886982072696
• UDI-Public: (01)10886982072696
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2021

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: 03.113.001
• Device Catalogue Number: 03.113.001
• Device Lot Number: 9290243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Initial Date Received by Manufacturer: 02/14/2021
• Supplement Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 04/06/2021
• 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: 3.5MM LCP LOW BEND MEDIAL DSTL TIBIA PLATE; INSERTN HANDLE F/3.5MM LOW BND PLATE; 3.5MM LCP LOW BEND MEDIAL DSTL TIBIA PLATE; INSERTN HANDLE F/3.5MM LOW BND PLATE
• Patient Age: 66 YR
• Patient Weight: 98