MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT SZ8/9 TAPERED REAMER; TRIAL/INSTRUMENT

Catalog Number	257002400
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2017
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
It was reported that the size 8/9 summit tapered reamer was damaged at its connecting end and during instrument assembly in mdrd, it was noticed that it would not hold on to the reamer attachment and that the reamer looked dull compared to others in the set.No surgical delay.
Additional Manufacturer Narrative
(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.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SUMMIT SZ8/9 TAPERED REAMER
• Common Device Name: TRIAL/INSTRUMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 7078136
• Report Number: 1818910-2017-50672
• Device Sequence Number: 13658268
• Product Code: HTO
• UDI-Device Identifier: 10603295143031
• UDI-Public: 10603295143031
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2017

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: 257002400
• Device Lot Number: SO2010071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2018
• Initial Date Received by Manufacturer: 11/06/2017
• Supplement Date Received by Manufacturer: 01/16/2018; 07/02/2018
• Initial Report FDA Received Date: 12/03/2017
• Supplement Report FDA Received Date: 01/23/2018; 07/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1