MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC AIMING ARM FOR TI CANN TIBIAL NAILS-EX; ORTHOPAEDIC IMPLANT AIMING ARM

Model Number	03.010.052
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history review was performed, and no non-conformances were detected related to the reported condition.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j sales representative.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) 2022 that the knob that tightens the aiming arm for ti cann tibial nail-ex to the insertion handle tibial nail-ex insertion handle broke off from the actual bolt during an ex tibia nail procedure.The surgeon also attempted to remove the bolt from the aiming arm so that we could use a tightening knob from a rafn set however the bolt became cross threaded and could not be removed from the aiming arm.The doctor was able to use two lobster claws to tighten the aiming arm to the insertion handle for the insertion of the proximal locking screws and complete the procedure.There was a surgical delay of 10 minutes.Procedure was completed successfully.Patient outcome is stable.This report is for one (1) 9mm ti cann tibial nail-ex w/prox bend 375mm-sterile.This is report 1 of 2 for complaint (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.H10: additional narrative: 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.
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.H10 additional narrative: d10: date of concomitant therapy is april 3, 2022.H6: part: 03.010.052.Synthes lot: 3039981.Supplier lot: 3039981.Release to warehouse date: january 05, 2009.Manufactured by: n/a.Supplier: synthes gmbh oberdorf.No nonconformance reports (ncrs) generated during production.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.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the device from the received image.Visual analysis of the photo revealed that the knob of the aiming arm for ti cann tibial nails-ex broke off leaving the bolt tightened and the device assembled to the tibial insertion handle.Based on this finding it is reasonable to conclude that it is not possible to disassemble both the tibial insertion handle and aiming arm.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for aiming arm for ti cann tibial nails-ex.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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: AIMING ARM FOR TI CANN TIBIAL NAILS-EX
• Common Device Name: ORTHOPAEDIC IMPLANT AIMING ARM
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14246154
• Report Number: 2939274-2022-01528
• Device Sequence Number: 4398222
• Product Code: FZX
• UDI-Device Identifier: 10886982067241
• UDI-Public: (01)10886982067241
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/28/2022

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: 03.010.052
• Device Catalogue Number: 03.010.052
• Device Lot Number: 3039981
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/03/2022
• Supplement Date Received by Manufacturer: 05/24/2022; 04/03/2022
• Initial Report FDA Received Date: 04/28/2022
• Supplement Report FDA Received Date: 05/24/2022; 05/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2009
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TIBIAL NAIL-EX INSERTION HANDLE; UNK - SCREWS: NAIL PROXIMAL
• Patient Age: 46 YR
• Patient Sex: Male