MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. TORQUE LIMITING HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	07.02053.001
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.Reference reports 3012447612-2020-00177.
Event or Problem Description
It was reported that during the procedure two torque handles were providing inconsistent torque.There was no further surgical information provided however, it was reported that a closure top, tightened by one of the torque handles, was found to have backed out 3 months postoperatively.This is report two of two for this event.
Additional Manufacturer Narrative
The returned torque handle was evaluated.Visual inspection found no device malfunction.Passed initial torque test, but others in the lot failed, resulting in recalibration of lot.Passed additional torque test after recalibrations.One non conformance was found during the device history review.This nc was a documentation nonconformance where some inspection steps were not properly marked on the record.The documentation was reworked and a note stating the lots were recalibrated was made.This ncr would not have contributed to the complaint event.There are no indications of manufacturing issues which would have contributed to this complaint event and the device was likely conforming when it left zimmer biomet¿s control.The alleged malfunction is unconfirmed as it passed torque test.
Event or Problem Description
T was reported that during the procedure two torque handles were providing inconsistent torque.There was no further surgical information provided however, it was reported that a closure top, tightened by one of the torque handles, was found to have backed out 3 months postoperatively.This is report two of two for this event.

• Brand Name: TORQUE LIMITING HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 9830678
• Report Number: 3012447612-2020-00179
• Device Sequence Number: 19023824
• Product Code: LXH
• UDI-Device Identifier: 00889024009790
• UDI-Public: (01)00889024009790(10)103346-042
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2020

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
• Operator of Device: Health Professional
• Device Catalogue Number: 07.02053.001
• Device Lot Number: 103346-042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/13/2020
• Supplement Date Received by Manufacturer: 05/22/2020
• Initial Report FDA Received Date: 03/13/2020
• Supplement Report FDA Received Date: 06/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1