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 07/02/2020

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 all calcar planars are dull and have been requested by surgeon to be replaced.

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.Territory 230 reported that all calcar planers are dull and have been requested by surgeon to be replaced.Examination of the returned instrument confirmed the complaint of dullness; planer is dull to the touch.Visual exam found the cutting was successfully used in the field as the cutting surface is heavily worn and the product information is near impossible to read.The complaint sample consisted (1) (b)(4) - modular calcar planer sml, lot pg268702.Review of as400 indicated this device was distributed for use on 17 oct 2017.A search of the complaint database found similar reports for product code and failure and the root cause was attributed to heavy use and wear out.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the investigation, the need for corrective action is not indicated.Complaints will be monitored under sep 419 post market surveillance.

• Brand Name: MODULAR CALCAR PLANER SML
• Type of Device: REAMERS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10262454
• MDR Text Key: 198548339
• Report Number: 1818910-2020-15620
• Device Sequence Number: 1
• Product Code: HTO
• 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: 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• 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: PG268702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Date Manufacturer Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR