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

Model Number 2055-16-000

Device Problems Defective Component (2292); Device-Device Incompatibility (2919)

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

Event Date 09/21/2020

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 during a bipolar hip procedure when trailing the bipolar components, the locking ring and 28mm trial head became dissociated from the bipolar trial.Upon further investigation it appears that the orange locking ring (cat#: 2055-16-000), which happens to be relative new, was smaller than the older locking rings.After the instruments were sterilized they tried different bipolar trials to confirm that the problem was the locking ring and not the bipolar trials.The disassociation occurs with other bipolar trials as well.Since we have three sets of bipolar instruments at this facility they opened the other two sets and identified one another locking ring that causes the same problem.Both of the rings causing the problem are relative new.They did notice that the new rings has text etched around the outer edge which was absent on the older locking rings.Ring#1: (b)(4).Ring#2: (b)(4).They both appear to have the same text.No surgical delay.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.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.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: 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: 10629207
• MDR Text Key: 209845999
• Report Number: 1818910-2020-21606
• Device Sequence Number: 1
• Product Code: LXH
• 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,Followup
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• 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: HW90103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2020
• Date Manufacturer Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR