MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT REVISION REAMER 13MM; KNEE INSTRUMENT/TRIAL

Catalog Number	217863173
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	10/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 reamers are scarred at the union from usage over the years.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Investigation summary functional testing of the returned device confirmed the reported event.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
Complaint description: it was reported that the reamers are scarred at the union from usage over the years.Investigation method: the complaint sample consisted of (4) (b)(4) modified hudson adapter, lot numbers tbpke, h0609, and tbltw.The remaining reported (b)(4) modified hudson adapter were not received for examination.Examination of the four submitted adapters confirmed the connection features that attach to the reamer are worn/damaged.The damage is consistent with the reamers mating feature stripping after being subjected to hard cortical bone and heavy usage causing damage/wear to the adapter.The root cause is attributed to product wear out.Based on the investiga-tion's determination of device wear from normal use and servicing, no corrective action is being pursued.Continue to monitor via sep-419.Investigation summary: it was reported that the reamers are scarred at the union from usage over the years.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Functional testing of the returned device confirmed the reported event.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.

• Brand Name: MBT REVISION REAMER 13MM
• Common Device Name: KNEE INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 7033856
• Report Number: 1818910-2017-28997
• Device Sequence Number: 155721
• Product Code: HTO
• UDI-Device Identifier: 10603295096306
• UDI-Public: 10603295096306
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/17/2017

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: 217863173
• Device Lot Number: NG0409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2017
• Initial Date Received by Manufacturer: 10/17/2017
• Supplement Date Received by Manufacturer: 08/13/2018; 10/31/2018
• Initial Report FDA Received Date: 11/15/2017
• Supplement Report FDA Received Date: 08/15/2018; 10/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1