MAUDE Adverse Event Report: SYNTHES GMBH RAD AIMING ARM/FRN PIRIFORMIS FOSSA; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	03.033.002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on an unknown date, an insertion handle aiming arm is in need of replacement or repair.The locking tabs have broken off.This report involves one (1) radiolucent aiming arm/frn piriformis fossa.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: reporter is a j&j employee.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Part# 03.033.002.Lot # l699798.Manufacturing site: werk hägendorf.Supplier: na.Release to warehouse date: 22 feb 2018.Expiration date: na.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: RAD AIMING ARM/FRN PIRIFORMIS FOSSA
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• 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: 18319184
• Report Number: 8030965-2023-15643
• Device Sequence Number: 7316538
• Product Code: HSB
• UDI-Device Identifier: 10886982271068
• UDI-Public: 10886982271068
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172157
• 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: Other Health Care Professional
• Type of Report: Initial,Followup

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 Catalogue Number: 03.033.002
• Device Lot Number: L699798
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2023
• Supplement Date Received by Manufacturer: 12/26/2023
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2018
• 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
• Patient Sex: Unknown