MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM BOLT TORQ WRENCH HNDL; RECLAIM INSTRUMENTS : WRENCHES

Model Number	2975-00-300
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/01/2021
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
Intraoperatively the instrument fractured.Surgery delay about 30 minutes.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary the device associated with this report was not returned for examination.Product photographs were not provided.The investigation can not draw any conclusions since the device was not returned for evaluation, and no photographs were provided.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: RECLAIM BOLT TORQ WRENCH HNDL
• Common Device Name: RECLAIM INSTRUMENTS : WRENCHES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12778540
• Report Number: 1818910-2021-24624
• Device Sequence Number: 3547923
• Product Code: HXC
• UDI-Device Identifier: 10603295155898
• UDI-Public: 10603295155898
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2021

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
• Device Model Number: 2975-00-300
• Device Catalogue Number: 297500300
• Device Lot Number: SO2047338
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2021
• Supplement Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2019
• 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