MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT BROACH SZ 5; HIP INSTRUMENTS : BROACHES

Model Number	2570-00-110
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2020
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 post broke off the sz6 broach and the sz 5 is bent.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the instrument associated with this report was not returned.Depuy-synthes 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.

• Brand Name: SUMMIT BROACH SZ 5
• Common Device Name: HIP INSTRUMENTS : BROACHES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10364637
• Report Number: 1818910-2020-17554
• Device Sequence Number: 19408536
• Product Code: HTO
• UDI-Device Identifier: 10603295142928
• UDI-Public: 10603295142928
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 07/27/2020

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 Model Number: 2570-00-110
• Device Catalogue Number: 257000110
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/27/2020
• Supplement Date Received by Manufacturer: 09/14/2020
• Initial Report FDA Received Date: 08/04/2020
• Supplement Report FDA Received Date: 09/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1