MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 P.F.C.* PRESS-FIT ROD WRENCH; KNEE INSTRUMENT : WRENCHES

Model Number 86-5189

Device Problems Mechanical Problem (1384); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: update 20-feb-2020: the investigation was re-opened upon the receipt of the product.Examination of the returned device found the wrench to be difficult to operate.The noted damage is consistent with excessive torque being used and the investigation did not establish a need for corrective action.Depuy synthes considers the investigation closed.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 will be filed as appropriate.

Event Description

The instrument was initially reported for an unknown reason.

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: update 20-feb-2020: the investigation was re-opened upon the receipt of the product.Examination of the returned device found the wrench to be difficult to operate.The noted damage is consistent with excessive torque being used and the investigation did not establish a need for corrective action.Depuy synthes considers the investigation closed.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 : WRENCHES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9806787
• MDR Text Key: 190811591
• Report Number: 1818910-2020-07084
• Device Sequence Number: 1
• Product Code: HXC
• UDI-Device Identifier: 10603295216759
• UDI-Public: 10603295216759
• 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
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 86-5189
• Device Catalogue Number: 865189
• Device Lot Number: GM0705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Date Manufacturer Received: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1