MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS; GUIDE, SURGICAL, INSTRUMENT

Model Number	357.366
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter is synthes 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 on (b)(6) 2020, the patient underwent an unknown procedure.During the procedure, the buttress/compression nut and the aiming arm would not click in.The procedure was successfully completed with no surgical delay.There was no patient consequence.This report is for one (1) 130 deg aiming arm f/trochanteric fixation nails.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, h4, h6: part 357.366, lot 7749269: manufacturing site: hägendorf.Release to warehouse date: february 29, 2012.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.H3, h6: a product investigation was completed: upon visual inspection, it was observed that the aiming arm cap component interface feature edges were slightly deformed and the outer surface was discolored.Several nicks were observed on the device.No other visual damages were observed on the device except normal wear which would not contribute to the reported complaint condition.The function test was performed with the returned complaint device (130 deg aiming arm) and the mating device (buttress/compress nut: 357.371).During the functional test, the mating device was assembled with complaint device and it was observed that assembly was too loose as the devices were not interfaced as intended.The alleged device interaction issue was caused due to the interface features deformation in both mating and complaint devices.Thus, the complaint condition was confirmed for the received device.The dimensional inspection was not performed as the complaint relevant dimensions cannot be checked for dimensional accuracy due to the post-manufacturing damage.The relevant drawings reflecting current and manufactured revisions were reviewed.The overall complaint was confirmed for the received device as the complaint device was unable to assemble with the mating device as intended.The resulted device interaction issue was occurred due to the deformed interface features in both mating and complaint devices.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.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
This is report 1 of 2 for (b)(4).

• Brand Name: 130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS
• 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: 10780267
• Report Number: 2939274-2020-04955
• Device Sequence Number: 3694560
• Product Code: FZX
• UDI-Device Identifier: 10886982196019
• UDI-Public: (01)10886982196019
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2020

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: 357.366
• Device Catalogue Number: 357.366
• Device Lot Number: 7749269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 11/30/2020
• 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: BUTTRESS/COMPRESSION NUT FOR 357.369; BUTTRESS/COMPRESSION NUT FOR 357.369