MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 MBT REV 13 MM CEM BUSHING; KNEE INSTRUMENT : DRILL GUIDES

Model Number	2178-63-196
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)
Date of Event	04/26/2018
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 when passing the cemented reamer through the bushing it got stuck and would not continue reaming.Need new parts sent to (b)(6) warehouse.
Additional Manufacturer Narrative
(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.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Event has incorrectly been reported as serious injury.Correct report type is malfunction only.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MBT REV 13 MM CEM BUSHING
• Common Device Name: KNEE INSTRUMENT : DRILL GUIDES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7542078
• Report Number: 1818910-2018-60464
• Device Sequence Number: 10794580
• Product Code: HWT
• UDI-Device Identifier: 10603295096528
• UDI-Public: 10603295096528
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/26/2018

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 Model Number: 2178-63-196
• Device Catalogue Number: 217863196
• Device Lot Number: H0310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2018
• Initial Date Received by Manufacturer: 04/26/2018
• Supplement Date Received by Manufacturer: 06/22/2018; 03/01/2021
• Initial Report FDA Received Date: 05/24/2018
• Supplement Report FDA Received Date: 07/04/2018; 03/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1