MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. TORQUE LIMITING HANDLE - 90; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	07.02053.001
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Three torque limiting handles were returned to the manufacturer for evaluation as part of a concern with malfunctioning drivers.The torque handles were subsequently tested and found to output torque above the required limit.This is report three of three for this event.
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.
Event or Problem Description
Three torque limiting handles were returned to the manufacturer for evaluation as part of a concern with malfunctioning drivers.The torque handles were subsequently tested and found to output torque above the required limit.This is report three of three for this event.
Additional Manufacturer Narrative
Corrections in h3.Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: the returned handles were each tested with all of the three returned long drivers.Internal checks indicated a potential for the drivers to be nonconforming.They were sent out to the calibration supplier for further testing.The supplier found the drivers to be conforming to calibration specifications.Visual inspection revealed that the drivers have no damage.The complaint is unrefuted for not tightening as expected.Root cause: root cause was unable to be determined.This event could possibly be attributed to wear through use over time or multiple sterilization cycles.Dhr review: per dhr review, the parts were likely conforming when they left zimvie control.Device usage: this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.

• Brand Name: TORQUE LIMITING HANDLE - 90
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 13606848
• Report Number: 3012447612-2022-00037
• Device Sequence Number: 1930248
• Product Code: LXH
• UDI-Device Identifier: 00889024009790
• UDI-Public: (01)00889024009790(10)130121-028
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2022

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: 130121-028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2022
• Supplement Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 02/25/2022
• Supplement Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown