MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US BIOSTOP G INSERTER T-HANDLE; MISCELLANEOUS JOINT INSTRUMENTS : INSERTION DEVICES

Model Number 5463-60-500

Device Problem Unintended Movement (3026)

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

Event Date 11/20/2020

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

When the nurse went to put there trial on the biostop inserter handle.There was some play and the trial felt loose.It was never like that.Most likely due to over usage.The handle should be replaced.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: examination of the returned device could not confirm the reported event.No evidence was found indicating product error was a contributing factor.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: BIOSTOP G INSERTER T-HANDLE
• Type of Device: MISCELLANEOUS JOINT INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11139365
• MDR Text Key: 225777101
• Report Number: 1818910-2021-00659
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295174721
• UDI-Public: 10603295174721
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5463-60-500
• Device Catalogue Number: 546360500
• Device Lot Number: A0309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Date Manufacturer Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1