MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ATTUNE SHIM SZ5 5MM; KNEE INSTRUMENT/TRIAL

Catalog Number 254500651

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 10/09/2017

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the instrument snapped when inserting for trial.

Manufacturer Narrative

(b)(4).Investigation summary
=
> the device associated with this report was not returned.The investigation could not verify or identify any product contribution to the reported event with the information provided as the reported device was not returned for evaluation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

The devices associated with this report were not returned.The investigation could not verify or identify any product contribution to the reported event with the information provided as the reported device was not returned for evaluation.Depuy considers the investigation closed at this time.Should the 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.

• Brand Name: ATTUNE SHIM SZ5 5MM
• Type of Device: KNEE INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic dr.; warsaw IN 46582
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork, munster IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic dr.; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 7007792
• MDR Text Key: 91501116
• Report Number: 1818910-2017-28246
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295133438
• UDI-Public: 10603295133438
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 254500651
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1