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

Model Number	2236-00-008
Medical Device Problem Codes	Dull, Blunt (2407); Failure to Cut (2587); Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	07/15/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: EXTREMITY INSTRUMENTS : REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10318346
• Report Number: 1818910-2020-16779
• Device Sequence Number: 3557411
• Product Code: HTO
• UDI-Device Identifier: 10603295105756
• UDI-Public: 10603295105756
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2020

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
• Operator of Device: Health Professional
• Device Model Number: 2236-00-008
• Device Catalogue Number: 223600008
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/15/2020
• Supplement Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 07/24/2020
• Supplement Report FDA Received Date: 08/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1