MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ROD FOR REAMING GUIDE HOLDER; KNEE INSTRUMENT

Catalog Number 230774002

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2017

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).

Event Description

This case is linked to: (b)(4) (procedure: reverse shoulder arthroplasty).Following the procedure the scrub nurse noticed the proximal reaming guide holder internal rod was bent under the top dial.The surgeon said he was not sure what happened.He thought it was already bent when it was handed to him, but the scrub nurse explained to him that is wasn't bent when he attached it.(b)(4) rep was in the case, and rep knew it wasn't bent when they set up, but (b)(4) rep did not see what happen during the case that bent it.

Manufacturer Narrative

Product complaint # pc-(b)(4).Investigation summary the complaint description states that following the procedure the scrub nurse noticed the proximal reaming guide holder internal rod was bent under the top dial.The device associated to the complaint was not returned for analysis.The batch number was not provided.Previous complaints have been reported for a "tip bent", the analysis revealed that the failure may be contributed to a lack of robust design against misuse.A design change is being investigated, in process co (b)(4).The affected product would need to be returned and examed to confirm if the root cause are related.Based on the information received and the investigation performed, the root cause of the incident could not be determined with certainty.Depuy considers this complaint closed.It may be re-opened if any relevant information is received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ROD FOR REAMING GUIDE HOLDER
• Type of Device: KNEE INSTRUMENT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; bp 256; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 7067139
• MDR Text Key: 93634755
• Report Number: 1818910-2017-50380
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10603295116134
• UDI-Public: 10603295116134
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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
• Report Date: 11/01/2017

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 230774002
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2017
• Initial Date FDA Received: 11/29/2017
• Supplement Dates Manufacturer Received: 06/05/2018
• Supplement Dates FDA Received: 06/07/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1