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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a single level tlif case, after final tightening of a closure top, the closure top and pedicle screw lost compression.This was due to the torque handle providing inadequate torque.The surgery was completed using a disposable torque handle to successfully perform the final locking again.There was no patient impact.
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.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.
Additional Manufacturer Narrative
Corrections in a1, d4: lot number & udi number, d9, and h3.Additional information in h4.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
Event or Problem Description
It was reported that during a single level tlif case, after final tightening of a closure top, the closure top and pedicle screw lost compression.This was due to the torque handle providing inadequate torque.The surgery was completed using a disposable torque handle to successfully perform the final locking again.There was no patient impact.
Additional Manufacturer Narrative
H3: "device evaluation anticipated, but not yet begun" is erroneous and no longer applies.The device was evaluated.Corrections in h3.Additional information in h4 and h6: investigation type, findings, and conclusions.Device evaluation: the returned device matches the information in the complaint file and was examined.Visual inspection revealed no signs of damage.A functional inspection was performed by testing the torque output on eq: 2661-b.The torque readings ranged from 90.9 in-lbs to 93.1 in-lbs.Per drawing 07.02053.001 rev.D, the torque out put should be 90 in-lbs +/- 5%.Root cause: a definitive root cause cannot be determined as the returned device was found to function as expected.Dhr review: 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 highridge medical's 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.
Event or Problem Description
It was reported that during a single level tlif case, after final tightening of a closure top, the closure top and pedicle screw lost compression.This was due to the torque handle providing inadequate torque.The surgery was completed using a disposable torque handle to successfully perform the final locking again.There was no patient impact.

• 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.; westminster CO 80021
• Manufacturer Contact: teresa george ; 10225 westmoor dr.; westminster, CO 80021 ; 3035018506
• MDR Report Key: 21548723
• Report Number: 3012447612-2025-00073
• Device Sequence Number: 8165058
• Product Code: LXH
• UDI-Device Identifier: 00889024009790
• UDI-Public: (01)00889024009790(10)159609-025
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/09/2025

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: 159609-025
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 03/24/2025; 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2024
• 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 Age: 88 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic