MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 MBT REVISION REAMER 16MM; KNEE INSTRUMENT : REAMERS

Model Number 2178-63-176

Device Problem Device-Device Incompatibility (2919)

Patient Problem Insufficient Information (4580)

Event Date 07/14/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).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 the stem trial will not fit properly on the 45 mm tibia broach.Stem trial will also not fit properly on the 34 mm and the 31 mm femoral broach.16 mm reamer comes loose from the hudson adapter.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: examination of the returned device revealed the reamer adaptor end was stripped.The noted damage and wear are consistent with device use from normal use and servicing and the investigation did not establish a need for corrective action.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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.Corrected: h3.

Event Description

Additional information received indicated that no pieces were broken off the instruments and there was no adverse consequences to the patient.

Manufacturer Narrative

Product complaint # : (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: MBT REVISION REAMER 16MM
• Type of Device: KNEE INSTRUMENT : REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; b.p. 256; warsaw IN 46581 0988
• MDR Report Key: 12273607
• MDR Text Key: 264933943
• Report Number: 1818910-2021-16945
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10603295096337
• UDI-Public: 10603295096337
• 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: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2178-63-176
• Device Catalogue Number: 217863176
• Device Lot Number: NG76026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Date Manufacturer Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1