MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 BROACH CORAIL AMT 16; HIP INSTRUMENTS : BROACHES

Model Number	L20416
Medical Device Problem Codes	Material Deformation (2976); Illegible Information (4050)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2020
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
Metal connection of broach was bent.Not useable.Broach number 16 corail.Neck piece getting stuck due to angle of bent metal.Difficult to remove.Unable to trial.No adverse events.No surgical delay.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.Depuy-synthes 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.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned.The investigation could not verify or identify any product contribution to the reported event with the information 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.

• Brand Name: BROACH CORAIL AMT 16
• Common Device Name: HIP INSTRUMENTS : BROACHES
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 11028665
• Report Number: 1818910-2020-27193
• Device Sequence Number: 629652
• Product Code: HTQ
• UDI-Device Identifier: 10603295258186
• UDI-Public: 10603295258186
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/04/2020

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: L20416
• Device Catalogue Number: L20416
• Device Lot Number: 1920714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Initial Date Received by Manufacturer: 12/04/2020
• Supplement Date Received by Manufacturer: 02/02/2021; 03/08/2021; 03/30/2021
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 02/02/2021; 03/15/2021; 03/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1