MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLENOSPHERE ORIENTATION GUIDE; EXTREMITY INSTRUMENTS : ALIGNMENT DEVICES

Model Number 2307-95-000

Device Problem Material Deformation (2976)

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

Event Date 04/26/2021

Event Type  malfunction  

Manufacturer Narrative

(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 glenosphere orientation guide tip was bent during glenosphere implantation.There were no broken pieces and no delay in the procedure.Instrument will be returned to distributor a1a.There is no further information available.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.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 product and lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: GLENOSPHERE ORIENTATION GUIDE
• Type of Device: EXTREMITY INSTRUMENTS : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11786631
• MDR Text Key: 249451205
• Report Number: 1818910-2021-09736
• Device Sequence Number: 1
• Product Code: HTZ
• UDI-Device Identifier: 10603295116592
• UDI-Public: 10603295116592
• Combination Product (y/n): N
• 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: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2307-95-000
• Device Catalogue Number: 230795000
• Device Lot Number: 5322127
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1