MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US BIPOLAR TRL RETAINING CLIP 28; HIP INSTRUMENTS : INSERTION DEVICES

Model Number 2055-16-000

Device Problem Device-Device Incompatibility (2919)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 10/28/2020

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 retention clip was visibly shrunken after being autoclaved.Rep had a backup ring from a different lot number so when it was seen that clip had shrank, it was immediately removed from the case.Following the case, the rep trialed the clip in a bipolar head and confirmed that it did allow the 28 head to fall out.Tolerances are not nearly tight enough for the clip to do its job.This was the 3rd time with the same lot number, same hospital and same surgeon that this clip has shrank after being sterilized.Rep is currently borrowing another clip from a different lot number in order to be able to complete cases.No pieces broke off in patient, all pieces were recovered.Surgery time was not extended due to any complications from depuy products.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the instrument associated with this report was not returned.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.

• Brand Name: BIPOLAR TRL RETAINING CLIP 28
• Type of Device: HIP INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10829637
• MDR Text Key: 215958977
• Report Number: 1818910-2020-24433
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295084501
• UDI-Public: 10603295084501
• 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: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2055-16-000
• Device Catalogue Number: 205516000
• Device Lot Number: HW90342
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1