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

Model Number 2570-04-501

Device Problem Dull, Blunt (2407)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2020

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 that the post broach does not properly seat a neck.Calcar planar is dull.No surgical delay.

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.

• Brand Name: MODULAR CALCAR PLANER SML
• Type of Device: REAMERS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10672886
• MDR Text Key: 211289321
• Report Number: 1818910-2020-22205
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 10603295482024
• UDI-Public: 10603295482024
• 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: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2570-04-501
• Device Catalogue Number: 257004501
• Device Lot Number: PG272842
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR