MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM PRONGED STEM STBLZR; RECLAIM INSTRUMENTS : INSERTION DEVICES

Model Number 2975-00-400

Device Problem Use of Device Problem (1670)

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

Revision hip using reclaim.The assembly tool has worn/galled threads that produced a small metal fragment (from the threads) when removed.Also, the bolt torque wrench body was missing the black plastic piece that supports the neck when torquing the locking bolt.

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: RECLAIM PRONGED STEM STBLZR
• Type of Device: RECLAIM INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11778181
• MDR Text Key: 249080263
• Report Number: 1818910-2021-09595
• Device Sequence Number: 1
• Product Code: HWR
• UDI-Device Identifier: 10603295155904
• UDI-Public: 10603295155904
• 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: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2975-00-400
• Device Catalogue Number: 297500400
• Device Lot Number: NB144637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Date Manufacturer Received: 05/20/2021
• Patient Sequence Number: 1