MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*WEIGHT HAMMER SLIDE; HIP INSTRUMENTS : IMPACTION INSTRUMENTS

Model Number	53-1205
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	08/06/2020
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
S-rom extractor has a split on the handle.Cannot dismantle the hook from the extractor handle.No surgical delay or patient consequences reported.
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.

• Common Device Name: HIP INSTRUMENTS : IMPACTION INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10449757
• Report Number: 1818910-2020-18718
• Device Sequence Number: 3316916
• Product Code: HWB
• UDI-Device Identifier: 10603295171553
• UDI-Public: 10603295171553
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2020

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: 53-1205
• Device Catalogue Number: 531205
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/14/2020
• Supplement Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1