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

Model Number 96-1673

Device Problems Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 09/11/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: examination of the returned devices found the adapter was jammed/stuck inside the torque wrench.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.

Event Description

It was reported that the instrument was reported for unknown reason.

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.H6 patient code: no code available (3191) used to capture the surgery prolonged and insufficient information.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Femoral adapter became stuck in the tensioning tool causing a delay in the surgery.We had to use a 2nd implant to complete the case.Was surgery delayed due to the reported event? yes, if yes, number of minutes: 20.

Manufacturer Narrative

Product complaint # : (b)(4).Investigation summary : examination of the returned devices found the adapter was jammed/stuck inside the torque wrench 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).A manufacturing records evaluation (mre) was not performed.

• 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
• MDR Report Key: 10740735
• MDR Text Key: 213209365
• Report Number: 1818910-2020-23367
• Device Sequence Number: 1
• Product Code: HXC
• UDI-Device Identifier: 10603295239789
• UDI-Public: 10603295239789
• 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: 09/25/2020

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: 96-1673
• Device Catalogue Number: 961673
• Device Lot Number: A0211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2020
• Initial Date Manufacturer Received: 10/12/2020
• Initial Date FDA Received: 10/27/2020
• Supplement Dates Manufacturer Received: 11/09/2020; 08/09/2021
• Supplement Dates FDA Received: 11/19/2020; 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR