MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM PROX TRIAL SHAFT 75; RECLAIM INSTRUMENTS : FEMORAL TRIALS

Model Number 2975-29-075

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 09/14/2021

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 that upon trialing the 75 body, the screw that attaches to the stem broke into three pieces.All of those pieces were retrieved.Roughly 2 minutes of additional time was required to secure the broken trial body.

Manufacturer Narrative

Product complaint #
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> (b)(4) investigation summary
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> no device was received for examination, therefore the reported event could not be confirmed.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
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> a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: RECLAIM PROX TRIAL SHAFT 75
• Type of Device: RECLAIM INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• 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: 12547697
• MDR Text Key: 273812799
• Report Number: 1818910-2021-21431
• Device Sequence Number: 1
• Product Code: LZY
• UDI-Device Identifier: 10603295156260
• UDI-Public: 10603295156260
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K903084
• 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
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2975-29-075
• Device Catalogue Number: 297529075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1