MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 MBT REVISION REAMER 19MM; KNEE INSTRUMENT : REAMERS

Catalog Number	217863179
Medical Device Problem Codes	Material Deformation (2976); Naturally Worn (2988)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 investigation's determination of device wear from normal use and servicing, no corrective action is being pursued.Continue to monitor via (b)(4) / | investigation summary: it was reported that the reamers are scarred at the union from usage over the years 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) 217863136 modified hudson adapter, lot numbers tbpke, h0609, and tbltw.The remaining reported 217863136 modified hudson adapter were not received for examination.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: examination and 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.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Examination and 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 19MM
• Common Device Name: KNEE INSTRUMENT : REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7676919
• Report Number: 1818910-2018-64177
• Device Sequence Number: 19220880
• Product Code: HTO
• UDI-Device Identifier: 10603295096368
• UDI-Public: 10603295096368
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Caregivers
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/15/2018

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: 217863179
• Device Lot Number: NG1108
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/15/2018
• Supplement Date Received by Manufacturer: 08/13/2018; 10/31/2018
• Initial Report FDA Received Date: 07/11/2018
• Supplement Report FDA Received Date: 09/03/2018; 10/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1