MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US APG+ ACCESS REAMER 40; EXTREMITY INSTRUMENTS : REAMERS

Model Number 2236-00-008

Device Problems Dull, Blunt (2407); Failure to Cut (2587); Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 07/15/2020

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 38 poly trials are damaged with scars and missing plastic in areas surgeon and spd wanted them replaced.Protective plate is bent and won¿t sit flush on the bone.The reamers are dulled and have burrs.These items were pulled out of the sets and not used in a case.No surgical delay.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.The previous reported device code failure to cut is being corrected to more appropriate code which is dull or blunt.

• Brand Name: APG+ ACCESS REAMER 40
• Type of Device: EXTREMITY INSTRUMENTS : REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10318343
• MDR Text Key: 200237955
• Report Number: 1818910-2020-16778
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10603295105756
• UDI-Public: 10603295105756
• 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: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2236-00-008
• Device Catalogue Number: 223600008
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1