MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. CROSS CONNECTOR TORQUE WRENCH; WRENCH (RATCHETING HANDLES)

Catalog Number 94624

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/14/2022

Event Type  malfunction  

Event Description

It was reported that the tip of a polaris 5.5 cross connector torque wrench did not engage with the plugs on the cross connector intra-op.The torque wrench was switched out with the second copy, and the second copy worked fine.The surgery was completed without patient impacts.

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

Manufacturer Narrative

Review of information found that the incorrect as-reported failure modes were communicated, leading to an incorrect reportability decision; this event is not reportable.

Event Description

Review of information found that the incorrect as-reported failure modes were communicated, leading to an incorrect reportability decision.Therefore, there are corrections to all fields.

• Brand Name: CROSS CONNECTOR TORQUE WRENCH
• Type of Device: WRENCH (RATCHETING HANDLES)
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; na; westminster CO 80021
• Manufacturer Contact: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 15788346
• MDR Text Key: 305685168
• Report Number: 3012447612-2022-00262
• Device Sequence Number: 1
• Product Code: HXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 94624
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1