MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 GLOBAL FX POSITIONING JIG; EXTREMITY INSTRUMENTS : ALIGNMENT DEVICES

Catalog Number	212801035
Medical Device Problem Codes	Crack (1135); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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
Weld holding jig adjusting screw has cracked and is no longer holding adjusting screw to jig.
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.Product complaint # (b)(4).Investigation summary : based on the information received and the investigation performed, the cause of the complaint is unintended disassembly of the components.The definitive cause of the failure can ultimately not be determined.A potential cause is weakening of the weld joint during repeated use, causing the instrument to disassemble during transport.Based on the complaint it is unclear if parts were disassembled in situ or after when they were received in processing.The event will continue to be monitored per the applicable pms plan and monitored for triggers.No corrective action is required.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: GLOBAL FX POSITIONING JIG
• Common Device Name: EXTREMITY INSTRUMENTS : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9111430
• Report Number: 1818910-2019-105976
• Device Sequence Number: 3588227
• Product Code: HWT
• UDI-Device Identifier: 10603295088103
• UDI-Public: 10603295088103
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2019

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: 212801035
• Device Lot Number: SO2020148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Initial Date Received by Manufacturer: 09/03/2019
• Supplement Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 09/24/2019
• Supplement Report FDA Received Date: 11/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1