MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PFC* FLUT TIB ROD TRL 115 X 14; KNEE INSTRUMENT : TIBIAL STEM TRIALS

Catalog Number 866884

Device Problems Break (1069); Difficult to Remove (1528); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2019

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 inserter tip broke off inside trial stem.Both pieces retrieved and no surgical delay happen.

Manufacturer Narrative

Product complaint (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint (b)(4).Investigation summary: examination of the returned device found damage secondary to the broken mating device.There is no evidence of device breakage or product error.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, a follow-up medwatch will be filed as appropriate.

• Type of Device: KNEE INSTRUMENT : TIBIAL STEM TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8750517
• MDR Text Key: 149794536
• Report Number: 1818910-2019-97309
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10603295217664
• UDI-Public: 10603295217664
• 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: 06/11/2019

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 Catalogue Number: 866884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Initial Date Manufacturer Received: 06/11/2019
• Initial Date FDA Received: 07/01/2019
• Supplement Dates Manufacturer Received: 07/08/2019; 08/01/2019
• Supplement Dates FDA Received: 07/30/2019; 08/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 51 YR