MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 SOCKET PUSHER F/22.225 I/D CUP; HIP INSTRUMENTS : RETRACTORS

Model Number	9626-07-000
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2020
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
The two instruments arrived the hospital with crack in the plastic.Where / when did the event occur? other arrived with crack.What action was taken/required to manage the problem during the procedure has not been in use.Was a patient involved: no.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > the instrument associated with this report was not returned.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.

• Brand Name: SOCKET PUSHER F/22.225 I/D CUP
• Common Device Name: HIP INSTRUMENTS : RETRACTORS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10900386
• Report Number: 1818910-2020-25475
• Device Sequence Number: 2489682
• Product Code: HWR
• UDI-Device Identifier: 10603295243311
• UDI-Public: 10603295243311
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2020

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: 9626-07-000
• Device Catalogue Number: 962607000
• Device Lot Number: CL2346301
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 12/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1