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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: the remainder of the udi number is unknown because the lot number is not available.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.Reference report 3012447612-2025-00219.
Event or Problem Description
It was reported that intra-operatively, two torque limiting handles did not provide adequate torque, allowing for rod movement during compression.Another torque handle was used to complete the procedure with no patient impact.This is report two of two for this event.
Event or Problem Description
It was reported that intra-operatively, two torque limiting handles did not provide adequate torque, allowing for rod movement during compression.Another torque handle was used to complete the procedure with no patient impact.This is report two of two for this event.
Additional Manufacturer Narrative
If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
Additional Manufacturer Narrative
H3: "device evaluation anticipated, but not yet begun" is erroneous and no longer applies.The device was evaluated.H6: additional method code: 4109.Corrections in h3.Additional information in 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.The torque output was tested with load cell id: 2662-a/2662-b.The torque output of the handle ranged from 45.0 in-lbs to 46.5 in-lbs.Per drawing 07.02053.001 rev.D, the torque output should be 90 in-lbs +/- 5% (85.5 in-lbs to 94.5 in-lbs).The handle was sent to gauthier for evaluation, and was found to be out of specification.Root cause: this event could be attributed to lack of routine calibration as the device had not been returned for recalibration in nearly six years.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 intra-operatively, two torque limiting handles did not provide adequate torque, allowing for rod movement during compression.Another torque handle was used to complete the procedure with no patient impact.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
• 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: 22060405
• Report Number: 3012447612-2025-00220
• Device Sequence Number: 20786457
• Product Code: LXH
• UDI-Device Identifier: 00889024009790
• UDI-Public: (01)00889024009790(10)103346-028
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/16/2025

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: 103346-028
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 07/09/2025; 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2017
• 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
• Patient Ethnicity: Non Hispanic