MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 MODULAR CALCAR PLANER LRG; REAMERS

Model Number 2570-04-503

Device Problem Dull, Blunt (2407)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/07/2020

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 the 40mm and 48mm calcar planars are dull and will no longer remove bone.No surgical delay.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned.The investigation could not verify or identify any product contribution to the reported event with the information provided.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

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.

• Brand Name: MODULAR CALCAR PLANER LRG
• Type of Device: REAMERS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10700983
• MDR Text Key: 212520920
• Report Number: 1818910-2020-22809
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10603295482031
• UDI-Public: 10603295482031
• 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: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2570-04-503
• Device Catalogue Number: 257004503
• Device Lot Number: PG271359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Initial Date Manufacturer Received: 10/07/2020
• Initial Date FDA Received: 10/19/2020
• Supplement Dates Manufacturer Received: 12/02/2020; 03/07/2021
• Supplement Dates FDA Received: 12/04/2020; 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1