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

Model Number 2307-74-101

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2020

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

It was reported that both the 145 reaming guide and 145 stem inserter handles ceased up before ever being used in a case.Lubrication did not help the issue.No surgical delay.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device was received for examination, therefore the reported event could not be confirmed.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 lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: XTND 145 RSA REAM GUID INSRTR
• Type of Device: INSERTION DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11117124
• MDR Text Key: 225078827
• Report Number: 1818910-2021-00191
• 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: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• 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
• Device Lot Number: FE2081684
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1