MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT REVISION REAMER 17MM; KNEE INSTRUMENT/TRIAL

Model Number	2178-63-177
Medical Device Problem Codes	Dull, Blunt (2407); Naturally Worn (2988)
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 # : (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.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.  h10 additional narrative:  corrected: d10 & h3.Product complaint # = > (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.Device history lot = > null.Device history batch = > null.Device history review = > null.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.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.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint#: (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.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MBT REVISION REAMER 17MM
• Common Device Name: KNEE INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7034277
• Report Number: 1818910-2017-29015
• Device Sequence Number: 102279
• Product Code: HTO
• UDI-Device Identifier: 10603295096344
• UDI-Public: 10603295096344
• 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,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 Model Number: 2178-63-177
• Device Catalogue Number: 217863177
• 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; 01/23/2020
• Initial Report FDA Received Date: 11/15/2017
• Supplement Report FDA Received Date: 09/03/2018; 10/31/2018; 01/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1