MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT ANT STEM INSERT SHAFT; HIP INSTRUMENTS : INSERTION DEVICES

Catalog Number	259807450
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Examination of the returned instrument confirmed the complaint.The root cause is attributed to use error through off axis impact.Based on the risk assessment conducted, corrective action is not warranted at this time.Complaints will be monitored under (b)(4) post market surveillance.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.
Event or Problem Description
It was reported that the tip of the summit anterior inserter broke off at some point and needs to be replaced.I noticed it today before this procedure.Please send p1 to (b)(6).No surgical delay.

• Brand Name: SUMMIT ANT STEM INSERT SHAFT
• Common Device Name: HIP INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9078261
• Report Number: 1818910-2019-104985
• Device Sequence Number: 2452127
• Product Code: HWR
• UDI-Device Identifier: 10603295148432
• UDI-Public: 10603295148432
• 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): 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 259807450
• Device Lot Number: PG0708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 09/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1