MAUDE Adverse Event Report: DEPUY SYNTHES SPINE TORQUE WRENCH

Model Number 277040510

Device Problem Output above Specifications (1432)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/25/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Lot unknown a follow up report will be filed upon completion of the investigation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device not yet returned for evaluation.

Event Description

It was reported that during the posterior fusion, both hex tips broke into the head of the screws, during the final tightening both tips are still in the head of the screws (implanted) completed with same/like product.

Manufacturer Narrative

The torque wrench handle was returned for evaluation.Visual inspection found signs of superficial wear.Torque testing found the device to be out of specification.Device was disassembled and it was noted that there seemed to be little signs of lubrication.Ratchet showed signs of abrasive wear.The device is approximately 10 years old.It is suspected the device has been used numerous times/torque cycles.A review of the complaint trend analysis was performed and no systemic trend was identified as a result of the analysis.The root cause cannot positively be determined however it is possible wear, and damage to its components over more than 10 years of uses, resulted in the device exerting more torque than intended.As there has been no systemic trends observed, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TORQUE WRENCH
• Type of Device: WRENCH
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 6794995
• MDR Text Key: 82789640
• Report Number: 1526439-2017-10653
• Device Sequence Number: 1
• Product Code: HXC
• UDI-Device Identifier: 10705034196770
• UDI-Public: (01)10705034196770
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 277040510
• Device Catalogue Number: 277040510
• Device Lot Number: E0602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1