MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. TORQUE INDICATING WRENCH, 110IN-LBS; WRENCH (RATCHETING HANDLES)

Catalog Number 2000-9082

Device Problem Material Twisted/Bent (2981)

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

Event Date 11/07/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).Without a product return, no product evaluation is able to be conducted.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.

Event Description

It was reported that during the procedure the tip of the torque indicating wrench twisted.No additional surgical information was provided and there was no reported patient harm.

Manufacturer Narrative

Additional information in b4, g4, h2, h3, h4, h6: methods, results, and conclusion codes.The complaint is confirmed for one (1) of one (1) polaris 5.5 torque wrench (pn 2000-9082) for the failure of a twisted tip.The severity of this event is 0 (rmr-00090).This device is used for treatment.No medical records were provided with the complaint.The part was not returned for evaluation, but photos were provided and show that the tip of the instrument is twisted.The complaint is confirmed.The dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left zimmer biomet¿s control.A complaint history review was conducted for part # 2000-9082 and lot # b342139.The search for the lot # included all complaints for the lifetime of the lot and the search for the part # included all complaints for the year prior to the notification date of this complaint through when the complaint data was pulled (november 9, 2018 to october 12, 2020).The search identified 2 additional complaints for the same lot (b342139).The search also identified 4 other complaints for the device for the same or similar issue.The 2 complaints identified from the same lot are for fractured tips.A definitive root cause can not be determined for this issue.The device may have undergone multiple procedures and processes or a single event that could have contributed to the resulting fracture.It is possible that an off-axis force was applied while in use or that the driver was improperly seated with the screw head, increasing stresses while torquing, leading to tip fracture.It's also possible the torque indicating wrench was turned past the aligned arrows, resulting in a torsion failure.

Event Description

It was reported that during the procedure the tip of the torque indicating wrench twisted.No additional surgical information was provided and there was no reported patient harm.

• Brand Name: TORQUE INDICATING WRENCH, 110IN-LBS
• Type of Device: WRENCH (RATCHETING HANDLES)
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 9397333
• MDR Text Key: 168882015
• Report Number: 3012447612-2019-00531
• Device Sequence Number: 1
• Product Code: HXC
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2000-9082
• Device Lot Number: B342139-9
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 87