MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT BRAOCH SZ1; HIP INSTRUMENTS : BROACHES

Model Number 2570-00-070

Device Problems Dull, Blunt (2407); Material Twisted/Bent (2981); Illegible Information (4050)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/05/2020

Event Type  malfunction  

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 Description

Size etchings are worn and not legible, and edges are dull and not adequate in cutting bone.

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 BRAOCH SZ1
• Type of Device: HIP INSTRUMENTS : BROACHES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9867885
• MDR Text Key: 188361739
• Report Number: 1818910-2020-08890
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10603295142881
• UDI-Public: 10603295142881
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2570-00-070
• Device Catalogue Number: 257000070
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1