MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 XTND 145 RSA REAM GUID INSRTR

Model Number 2307-74-101

Device Problems Break (1069); Device-Device Incompatibility (2919)

Patient Problem Insufficient Information (4580)

Event Date 03/25/2021

Event Type  malfunction  

Manufacturer Narrative

(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

It was reported that the 145 degree guide inert handle was improperly connected to the reamer guide which ended inn breaking the locking mechanism on the handle.Surgical delay of 3 minutes.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: XTND 145 RSA REAM GUID INSRTR
• Type of Device: REAM GUID INSRTR
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11648978
• MDR Text Key: 244899493
• Report Number: 1818910-2021-07648
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 10603295518792
• UDI-Public: 10603295518792
• Combination Product (y/n): N
• PMA/PMN Number: K192855
• 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: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2307-74-101
• Device Catalogue Number: 230774101
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR