MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT S4/5 TAPERED REAMER; HIP INSTRUMENTS : REAMERS

Catalog Number	257002200
Medical Device Problem Codes	Naturally Worn (2988); Scratched Material (3020)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/22/2018
Type of Reportable Event	Malfunction
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.Visual analysis found nicks at the tip of the attachment end.The flat areas on the attachment end are stripped / worn.The fluted area of the reamer also exhibits nicks with missing material.The root cause is attributed to wear out.For the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
We were informed that the summit tapered reamer size 4/5 is damaged at the connecting end.There was no surgical delay.The surgery was completed without delay.There looked to be slight damage to the end of the reamer where it connects to the t-handle or reamer attachment.Lot # for the item is a0905.

• Brand Name: SUMMIT S4/5 TAPERED REAMER
• Common Device Name: HIP INSTRUMENTS : REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9027112
• Report Number: 1818910-2019-104346
• Device Sequence Number: 19393481
• Product Code: HTO
• UDI-Device Identifier: 10603295143017
• UDI-Public: 10603295143017
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2018

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: 257002200
• Device Lot Number: A0905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Initial Date Received by Manufacturer: 08/29/2019
• Supplement Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 09/13/2019
• Supplement Report FDA Received Date: 09/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1