MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC AIMING ARM FOR SUPRAPATELLAR; NAIL,FIXATION,BONE

Model Number	03.010.441
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Reporter is a j&j sales 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 an unknown procedure while inserting the nail, carbon fiber tibial nail jig broke.It is unknown if there were fragments generated.It is unknown if there was surgical delay reported and if the procedure was successfully completed.There were no patient consequences.Concomitant devices reported: unknown tibial nail (part # unknown; lot # unknown; quantity:1), unknown insertion handle (part # unknown; lot # unknown; quantity:1).This complaint involves one (1) device.This report is for (1) aiming arm for suprapatellar.This report is 1 of 1 (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.H3, h4, h6: investigation summary: background: it was reported that on (b)(6) 2021 during an unknown procedure while inserting the nail, carbon fiber tibial nail jig broke.It is unknown if there were fragments generated.It is unknown if there was surgical delay reported and if the procedure was successfully completed.Concomitant devices reported: unknown tibial nail (part# unknown; lot# unknown; quantity:1).Unknown insertion handle (part# unknown; lot# unknown; quantity:1).This complaint involves one (1) device.Investigation flow: damage.Visual inspection: the aiming arm for suprapatellar (p/n: 03.010.441, lot number: 160277-101) was received at us cq.Visual inspection of the complaint device showed the aiming arm connection component had cracked and was still attached.Device failure/defect was identified.Dimensional inspection: a dimensional inspection was not performed due to device geometry.Document/specification review: 03_010_441 rev f (current) and rev d (manufactured) were reviewed.No design issues or discrepancies were identified.Complaint was confirmed.Investigation conclusion: this complaint is confirmed as the aiming arm connection component had cracked and was still attached.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.H3, h4, h6: device history lot : part: 03.010.441.Lot: 160277-101.Manufacturing site: selzach.Supplier: (b)(4).Release to warehouse date: 06.Oct.2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 FOR SUPRAPATELLAR
• Common Device Name: NAIL,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11624708
• Report Number: 2939274-2021-01720
• Device Sequence Number: 19887665
• Product Code: JDS
• UDI-Device Identifier: 10886982068835
• UDI-Public: 10886982068835
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111667
• 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): 03/09/2021

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: 03.010.441
• Device Catalogue Number: 03.010.441
• Device Lot Number: 160277-101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - INSERTION INSTRUMENTS; UNK - NAILS: TIBIAL