MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC AIM ARM FOR 3.5 VA-LCP PROXIMAL TIBIA PL; PLATE,FIXATION,BONE

Model Number	03.127.009
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional product code: hwc.Reporter is a j&j representative.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, during a procedure, the aiming arm for the va proximal tibia plate set was dropped on the floor and was broken.There were no adverse effects for the patient and surgery was not delayed.This complaint involves one (1) device.This report is for (1)aim arm for 3.5 va-lcp proximal tibia pl.This report is 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.D7.H3, h6: part: 03.127.009-us.Lot: 9102117.Manufacturing site: hegendorf.Release to warehouse date: 23 october 2014.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Visual inspection: the aim arm for 3.5 va-lcp proximal tibia pl (part# 03.127.009, lot# 9102117) was returned and received at us customer quality (cq).Upon visual inspection at cq, it is observed that a piece of the tibial plate was broken, and the broken fragment was not received.No other issues were observed with the returned device.The provided photograph was reviewed and no additional issues were observed.Device failure/defect identified? yes.Dimensional inspection: a dimensional inspection for the received device was not performed due to post-manufacturing damage.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the device was received broken.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.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: AIM ARM FOR 3.5 VA-LCP PROXIMAL TIBIA PL
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12433166
• Report Number: 2939274-2021-05204
• Device Sequence Number: 4104928
• Product Code: HRS
• UDI-Device Identifier: 10886982075093
• UDI-Public: (01)10886982075093
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K120689
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2021

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: 03.127.009
• Device Catalogue Number: 03.127.009
• Device Lot Number: 9102117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2021
• Initial Date Received by Manufacturer: 08/09/2021
• Supplement Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 09/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1