MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US METAGLENE HOLDER; EXTREMITY INSTRUMENTS : HANDLES

Model Number 2307-87-005

Device Problem Structural Problem (2506)

Patient Problem Insufficient Information (4580)

Event Date 03/02/2022

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 the screwdriver was not locking securely onto metaglene.There was no surgical delay.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the device associated with this report was received for examination.During analysis, the device was assembled to a mating device in order to perform a functional test.Metaglene holder was assembled correctly into the mating devices and the metaglene plate was able to remain hold without any issue.The complaint is not 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).A manufacturing records evaluation (mre) was not performed.

• Brand Name: METAGLENE HOLDER
• Type of Device: EXTREMITY INSTRUMENTS : 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 46581-0988 ; 6107428552
• MDR Report Key: 13801964
• MDR Text Key: 287583137
• Report Number: 1818910-2022-04881
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 10603295116462
• UDI-Public: 10603295116462
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2307-87-005
• Device Catalogue Number: 230787005
• Device Lot Number: 5226938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• 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