MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM* CAP,IMPACTION; KNEE INSTRUMENT : IMPACTORS

Catalog Number	633805A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device revealed chipping.The noted damage is consistent with device use from normal use and servicing and the investigation did not establish a need for corrective action.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.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 impactor lps was damaged due to breakage.

• Common Device Name: KNEE INSTRUMENT : IMPACTORS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9129581
• Report Number: 1818910-2019-106597
• Device Sequence Number: 16722584
• Product Code: HWA
• UDI-Device Identifier: 10603295180692
• UDI-Public: 10603295180692
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/08/2019

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 Catalogue Number: 633805A
• Device Lot Number: PN375601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 09/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR