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

Catalog Number	223610008
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the reported device was not evaluated at the investigation site, however the device was evaluated by a depuy engineering technician and confirmed to be worn.Depuy 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.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
Surgeon reported reamer was blunt after the case.

• Brand Name: APG+ ACCESS REAMER 40 RU
• Common Device Name: EXTREMITY INSTRUMENTS : REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8186466
• Report Number: 1818910-2018-78917
• Device Sequence Number: 2792678
• Product Code: HTO
• UDI-Device Identifier: 10603295106050
• UDI-Public: 10603295106050
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/27/2018

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 Catalogue Number: 223610008
• Device Lot Number: PG247297
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 12/20/2018
• Patient Sequence Number: 1