MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 LOCKING SCREWDRIVER ROD; EXTREMITY INSTRUMENTS : SCREWDRIVERS

Model Number	2307-92-004
Medical Device Problem Codes	Break (1069); Material Deformation (2976); Naturally Worn (2988)
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 # = > pc-(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
It was reported that the instrument was reported to be broken/worn out.
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.
Event or Problem Description
A,event date? 06/21/2022.B.Please clarify which of the reported devices were worn.What feature is worn and not making it function as intended? the reamers have worn out c.Please clarify which of the reported devices were broken.Grippers.C.1 which part of the instrument/s broke? the heads of the screwdrivers.C.2 did the instrument broke into 2 or more pieces? if no, please specify what is the alleged deficiency of the instrument.Is it bent, cracked, stripped, worn or cross threaded? part of the gripper is bent.C.3 were all the pieces retrieved from the patient? yes.D.Was there any adverse consequences that affected the patient because of the reported event? no.E.Was there a surgical delay? if yes, what is the duration of the delay? no.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary : the device associated with this report was returned.After physical review it was identified that the rod is deformed/bent, therefore the allegation can be confirmed.The broken condition was not observed.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will 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: LOCKING SCREWDRIVER ROD
• Common Device Name: EXTREMITY INSTRUMENTS : SCREWDRIVERS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14914667
• Report Number: 1818910-2022-12278
• Device Sequence Number: 5813537
• Product Code: HXX
• UDI-Device Identifier: 10603295116578
• UDI-Public: 10603295116578
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• 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,Followup
• Report Date (Section B): 07/05/2022

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: 2307-92-004
• Device Catalogue Number: 230792004
• Device Lot Number: 5212761
• 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: 06/27/2022; 08/26/2022; 09/15/2022
• Initial Report FDA Received Date: 07/05/2022
• Supplement Report FDA Received Date: 07/12/2022; 08/29/2022; 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2013
• 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