MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 IMPACTOR TIP 32MM; HIP INSTRUMENTS : IMPACTORS

Model Number	9200-10-027
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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
(b)(6) staff at (b)(6) reporting a damaged impactor tip from consignment tray.No information on when the breakage occurs however a replacement item is required.Tip of impactor (that attaches to handle) has broken off.Lot number is unknown due to wear.
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: IMPACTOR TIP 32MM
• Common Device Name: HIP INSTRUMENTS : IMPACTORS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 11328211
• Report Number: 1818910-2021-02983
• Device Sequence Number: 19047060
• Product Code: HWA
• UDI-Device Identifier: 10603295221876
• UDI-Public: 10603295221876
• 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
• Report Date (Section B): 02/08/2021

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
• Operator of Device: Health Professional
• Device Model Number: 9200-10-027
• Device Catalogue Number: 920010027
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 02/15/2021
• Supplement Report FDA Received Date: 04/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1