MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 MBT REV PRIMARY CONICAL REAMER; KNEE INSTRUMENT : REAMERS

Catalog Number	217863199
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device found the locking feature to be stripped.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.The complaint sample consisted of (1) 217863199 mbt rev primary conical reamer.The mbt rev primary conical reamer was reported for unknown reason.Three follow-ups were conducted with the complainant to obtain event additional information.Please verify what is the alleged deficiency of the reported instrument? no additional event information was received.Examination of the submitted instrument revealed areas of wear and deformation on the corners of the flats.The damage to the instrument is consistent with the reamers stripping at the connection point between the reamer and the fitted adaptor after being subjected to hard cortical bone and heavy usage.The root cause is attributed to device wear from normal use and servicing.Based on this investigation's determination of device wear from normal use and servicing, no corrective action is being pursued.Complaint trends will be monitored by post market surveillance through sep-(b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.
Event or Problem Description
The instrument was reported for unknown reason.Office set, did not affect surgery or patient.Examination of the returned product by the product analyst determined that the locking feature appeared to be stripped, preventing proper functionality.

• Brand Name: MBT REV PRIMARY CONICAL REAMER
• Common Device Name: KNEE INSTRUMENT : REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• MDR Report Key: 8405003
• Report Number: 1818910-2019-86820
• Device Sequence Number: 16641869
• Product Code: HTO
• UDI-Device Identifier: 10603295096535
• UDI-Public: 10603295096535
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 217863199
• Device Lot Number: PG251513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 03/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1