MAUDE Adverse Event Report: SYNTHES GMBH 3.5/4.5 VA PROX FEM HOOK PL/LRG/291/LT/S; PLATE, FIXATION, BONE

Model Number	02.221.091S
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from synthes reports an event in the (b)(6) as follows: it was reported that a ppfx plate is broken.The patient had their revision surgery today.Unk - screws:(part# unknown; lot# unknown; quantity: unknown).This complaint involves one (1) device 3.5/4.5 va prox fem hook pl/lrg/291/lt/s.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a j&j employee.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.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.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.
Event or Problem Description
It was further reported, the patient had the primary fixation in (b)(6) 2021.The plate failed and the patient was revised on (b)(6), 2022 to a ppfx plate.That plate failed and the patient underwent another revision procedure to a long stem hip replacement on (b)(6), 2022.
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, h6: a photo investigation was completed: visual analysis of the provided photo revealed that a system construction is visible at the femur left with signs of bone fracture and the plate was observed broken.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.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: 3.5/4.5 VA PROX FEM HOOK PL/LRG/291/LT/S
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14205479
• Report Number: 8030965-2022-02681
• Device Sequence Number: 16604652
• Product Code: HRS
• UDI-Device Identifier: 10886982275967
• UDI-Public: (01)10886982275967
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K210205
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.221.091S
• Device Catalogue Number: 02.221.091S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/29/2022
• Supplement Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 04/26/2022
• Supplement Report FDA Received Date: 05/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - CABLE/WIRE: CERCLAGE WIRE.; UNK - SCREWS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 75 KG