MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 MBT REV CEM STEM REAMER 13MM; KNEE INSTRUMENT : REAMERS

Model Number 2178-63-185

Device Problem Connection Problem (2900)

Patient Problems No Consequences Or Impact To Patient (2199); Not Applicable (3189)

Event Date 04/26/2018

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event 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.

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.

Manufacturer Narrative

Product complaint # (b)(4).Event type has incorrectly been reported as serious injury in mwr-(b)(4).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 CEM STEM REAMER 13MM
• Type of Device: KNEE INSTRUMENT : REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7542093
• MDR Text Key: 109179672
• Report Number: 1818910-2018-60465
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295096429
• UDI-Public: 10603295096429
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 2178-63-185
• Device Catalogue Number: 217863185
• Device Lot Number: A1209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2018
• Initial Date Manufacturer Received: 04/26/2018
• Initial Date FDA Received: 05/24/2018
• Supplement Dates Manufacturer Received: 06/22/2018; 03/01/2021
• Supplement Dates FDA Received: 07/04/2018; 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1