MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC 1818910 MTO PINNACLE STR CUP IMPACTOR; OTHER PRODUCTS

Catalog Number	299966321
Medical Device Problem Codes	Dull, Blunt (2407); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/08/2017
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
It was reported that the mto pinnacle cup impactor was discovered at wash/sterilization to have the threaded tip insert extended from the face of the handle by approximately 1mm.A second handle was found with damaged threads.Both of these occurred after on use.Insert retaining pin appears to have sheared.No surgical delay.
Additional Manufacturer Narrative
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.Depuy 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MTO PINNACLE STR CUP IMPACTOR
• Common Device Name: OTHER PRODUCTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7167643
• Report Number: 1818910-2018-50343
• Device Sequence Number: 1823049
• Product Code: HWA
• UDI-Device Identifier: 10603295495048
• UDI-Public: 10603295495048
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/08/2017

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: 299966321
• Device Lot Number: BP071792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Initial Date Received by Manufacturer: 12/08/2017
• Supplement Date Received by Manufacturer: 04/02/2018; 09/10/2018
• Initial Report FDA Received Date: 01/05/2018
• Supplement Report FDA Received Date: 04/05/2018; 09/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1