MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ACTIS REAMER SZ 4 AND 5; REAMERS

Model Number 2011-01-230

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 06/29/2021

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

It was reported as "while reaming the femoral canal, the actis 4/5 reamer shaft sheared and broke off, leaving the reamer tip behind.Reamer tip was retrieved and removed from femur." surgical delay of 15 minutes.

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: ACTIS REAMER SZ 4 AND 5
• Type of Device: REAMERS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12211712
• MDR Text Key: 262942948
• Report Number: 1818910-2021-15763
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 10603295495680
• UDI-Public: 10603295495680
• Combination Product (y/n): N
• PMA/PMN Number: K150862
• 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: 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2011-01-230
• Device Catalogue Number: 201101230
• Device Lot Number: NG77130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Date Manufacturer Received: 08/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1