MAUDE Adverse Event Report: DEPUY IRELAND 9616671 HOLDER FOR REAMING GUIDES; EXTREMITY INSTRUMENTS : HANDLES

Model Number	2307-74-001
Medical Device Problem Codes	Break (1069); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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 information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
The rod broke into two pieces when attached to the reamer guide.The reamer guide size 10 is attached to the instrument.A smaller reamer guide was used to continue reaming.No surgical delay.No adverse affects on the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).Upon further review, it has been determined that there is no allegation against the device, no reportable event.Further updates will only be provided if additional information is received that changes the regulatory determination.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: HOLDER FOR REAMING GUIDES
• Common Device Name: EXTREMITY INSTRUMENTS : HANDLES
• 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14936422
• Report Number: 1818910-2022-12455
• Device Sequence Number: 14576244
• Product Code: LXH
• UDI-Device Identifier: 10603295116127
• UDI-Public: 10603295116127
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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,Followup
• Report Date (Section B): 07/06/2022

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: 2307-74-001
• Device Catalogue Number: 230774001
• Device Lot Number: 5110179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2022
• Supplement Date Received by Manufacturer: 07/25/2022; 09/14/2022
• Initial Report FDA Received Date: 07/06/2022
• Supplement Report FDA Received Date: 07/26/2022; 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2011
• 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