MAUDE Adverse Event Report: DEPUY IRELAND 9616671 GLEN RESURFACING REAMER D27 MM; EXTREMITY INSTRUMENTS : REAMERS

Model Number 2307-88-027

Device Problems Failure to Cut (2587); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2020

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 glenoid resurfacing reamer was no longer sharp.No surgical delay.

Manufacturer Narrative

Product complaint # : (b)(4).Investigation summary : the device associated with this report was not returned for examination.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.

• Brand Name: GLEN RESURFACING REAMER D27 MM
• Type of Device: EXTREMITY INSTRUMENTS : REAMERS
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 10271068
• MDR Text Key: 198720867
• Report Number: 1818910-2020-15780
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10603295116479
• UDI-Public: 10603295116479
• 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: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2307-88-027
• Device Catalogue Number: 230788027
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 90 YR