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

Model Number 2307-87-005

Device Problems Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 02/03/2022

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 while getting ready for the surgery the scrub tech was putting the glenoid template onto the blue screwdriver handle.However it would not stay seated, and kept falling off of the handle.So they used the other blue driver from that set which worked fine.The scrub tech handed off the defective driver to me, and upon inspection the tip of the driver doesn¿t seem to be expanding the way its supposed to.

Manufacturer Narrative

Product complaint # (b)(4).Mfr# 1818910-2022-02978 is being retracted since it was found to be a duplicate of mfr# 1818910-2022-03315.Mfr# 1818910-2022-03315 will be kept for investigation purposes.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was returned for analysis.Visual examination of the device was not able to confirm the reported allegation.Without the actual mating device, a functional test cannot be performed.However, the hex tip presents worn edges.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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: 13548748
• MDR Text Key: 286473910
• Report Number: 1818910-2022-02978
• 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,Followup
• Report Date: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 5246072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2022
• Initial Date FDA Received: 02/17/2022
• Supplement Dates Manufacturer Received: 02/24/2022; 07/01/2022
• Supplement Dates FDA Received: 03/04/2022; 07/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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 Sex: Female