MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT REVISION REAMER 16MM; KNEE INSTRUMENT : REAMERS

Model Number	2178-63-176
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device confirmed the reported event.The investigation attributed the root cause to normal use and servicing and did not establish that a broader investigation or corrective action was necessary.Depuy synthes 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
It was reported that all reamers were loose on the adapters and spun freely.Adapter would spin freely when attached to reamers or any other attachment.T-handle was also loose.Attachment point seems to be weak and came free at first sign of resistance.No pieces broke off in patient.All pieces were removed from patient.Surgery time was extended by approximately 30 as a result of depuy instruments not functioning properly.

• Brand Name: MBT REVISION REAMER 16MM
• Common Device Name: KNEE INSTRUMENT : REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11027869
• Report Number: 1818910-2020-27168
• Device Sequence Number: 629044
• Product Code: HTO
• UDI-Device Identifier: 10603295096337
• UDI-Public: 10603295096337
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/16/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 2178-63-176
• Device Catalogue Number: 217863176
• Device Lot Number: NG69931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 12/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1