MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 IMPACTOR TIP 36MM; HIP INSTRUMENTS : IMPACTORS

Model Number	9200-10-028
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2022
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
It was reported that the mi impactor tip is broken.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was returned.All available photo evidence was reviewed and it was identified that the tip of the device broken off, therefore the allegation can be confirmed.No other issues were observed.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: given that no lot number was able to be retrieved from the investigation, a manufacturing record evaluation (mre) review cannot be performed.

• Brand Name: IMPACTOR TIP 36MM
• Common Device Name: HIP INSTRUMENTS : IMPACTORS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• 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: 15258697
• Report Number: 1818910-2022-16188
• Device Sequence Number: 17613941
• Product Code: HWA
• UDI-Device Identifier: 10603295221883
• UDI-Public: 10603295221883
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 08/19/2022

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: 9200-10-028
• Device Catalogue Number: 920010028
• 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: 08/06/2022
• Supplement Date Received by Manufacturer: 10/31/2022; 11/03/2022
• Initial Report FDA Received Date: 08/19/2022
• Supplement Report FDA Received Date: 11/02/2022; 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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