MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG FEM ADPT TORQUE WRENCH; KNEE INSTRUMENT : TORQUE DEVICES

Model Number 96-1673

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/23/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: examination of the returned device revealed the plastic protector component is missing.The device was manufactured prior to a product enhancement and the investigation did not indicate that a broader investigation or corrective action was necessary.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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 torque wrench adapter was missing the inner plastic ring for tightening not used in case.No surgical delay.

• Brand Name: SIG FEM ADPT TORQUE WRENCH
• Type of Device: KNEE INSTRUMENT : TORQUE DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9578132
• MDR Text Key: 176692823
• Report Number: 1818910-2020-01536
• Device Sequence Number: 1
• Product Code: HXC
• UDI-Device Identifier: 10603295239789
• UDI-Public: 10603295239789
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 96-1673
• Device Catalogue Number: 961673
• Device Lot Number: A0410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1