MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT REV TAPERED CEMENT REAMER; KNEE INSTRUMENT : REAMERS

Catalog Number	217863106
Medical Device Problem Codes	Material Deformation (2976); Naturally Worn (2988)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	02/08/2019
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.Device is an instrument and is not implanted/explanted.
Event or Problem Description
The hudson attachment of this reamer was worn down.When used on powered hudson reamer and t-handle reamer, (tried to use with and without adaptor in instrument set) it would spin out when the reamer met resistance from the bone it was supposed to ream.Therefore not able to ream the bone.This reamer needs to be used to clear bone before broaching.No ae to the patient, 10 minutes delay in the surgery.
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.Additional narrative: added: evaluation codes.Product complaint # (b)(4).Investigation summary: the device was reviewed by depuy melbourne engineering.Root cause attributed to the device being used from normal use and servicing.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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 REV TAPERED CEMENT REAMER
• Common Device Name: KNEE INSTRUMENT : REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8379365
• Report Number: 1818910-2019-86085
• Device Sequence Number: 2926576
• Product Code: HTO
• UDI-Device Identifier: 10603295096054
• UDI-Public: 10603295096054
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: UNK
• 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,Followup
• Report Date (Section B): 02/08/2019

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: 217863106
• Device Lot Number: SO2001746
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/08/2019
• Supplement Date Received by Manufacturer: 05/03/2019
• Initial Report FDA Received Date: 02/28/2019
• Supplement Report FDA Received Date: 05/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1