MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MTO D OFF BRCH HDLE W ST PLT L; HANDLES

Catalog Number 299966306

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 02/04/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: as there was no reported failure, no confirmation of failure could occur but upon physical review of the instrument a scratched condition was identified.Depuy-synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.

Event Description

Product was received and investigation completed.It was reported that when surgeon broaching the femoral canal while impacting, the broach peg snapped in half.All pieces were recovered.A surgical delay of 10 minutes.

• Brand Name: MTO D OFF BRCH HDLE W ST PLT L
• Type of Device: HANDLES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581 ; 6107428552
• MDR Report Key: 11475417
• MDR Text Key: 239500467
• Report Number: 1818910-2021-05011
• Device Sequence Number: 1
• Product Code: HTQ
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 299966306
• Device Lot Number: AB4922535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Date Manufacturer Received: 02/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2019
• 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
• Patient Age: 68 YR