MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRIAL SPACER 12/14 +5; HIP INSTRUMENTS : FEMORAL TRIALS

Model Number 2038-20-000

Device Problems Break (1069); Crack (1135); Device-Device Incompatibility (2919)

Patient Problem Insufficient Information (4580)

Event Date 03/05/2021

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 as that the surgeon was trying to plane down the calcar over the broach, the calcar planar extremely dull and would not take any bone.Another tray was opened, but that was also very dull.Surgeon insisted on discarding that calcar planar and getting two new ones.When trialing the unipolar spacers, the +0 and +5 unipolar trial would not seat correctly on the neck trial.Surgeon lightly impacted them but the adapters both cracked.Both were discarded.Surgical delay of 5 minutes.

Event Description

Additional information received states that the instrument broke into two pieces.All pieces were retrieved from the patient.

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.Removed pe code visual: cracked.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 : 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.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: TRIAL SPACER 12/14 +5
• Type of Device: HIP INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11536861
• MDR Text Key: 243986233
• Report Number: 1818910-2021-05669
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 10603295084341
• UDI-Public: 10603295084341
• 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: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2038-20-000
• Device Catalogue Number: 203820000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1