MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC COUNTERTORQUE WRENCH FOR CSLP

Model Number 324.067

Device Problem Material Integrity Problem (2978)

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

Event Date 12/16/2021

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2021, the countertorque wrenches for cervical spine locking plate (cslp) were damaged during the removal surgery.Prongs were broken off and bent during case.Fragments were generated but they were removed easily without additional intervention.It was unknown if there was a surgical delay.The procedure was successfully completed.There was no patient consequence reported.This report is for (1) countertorque wrench for cslp.This is report 1 of 2 for complaint (b)(4).

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: COUNTERTORQUE WRENCH FOR CSLP
• Type of Device: WRENCH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13231496
• MDR Text Key: 286645979
• Report Number: 2939274-2022-00116
• Device Sequence Number: 1
• Product Code: HXC
• UDI-Device Identifier: 10705034769202
• UDI-Public: (01)10705034769202
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 324.067
• Device Catalogue Number: 324.067
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2021
• 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: Unknown
• Patient Sequence Number: 1