MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10NM TORQUE LIMITING RATCHET HANDLE-6MM HXC; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	03.620.061
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is expected to be returned for manufacturer review/ investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2022 during a posterior lumbar fusion procedure, at the end of the case, when final tightening or torqueing the last set screw the torque handle kept spinning and tightening the set screw but never torqued out.Finally the amount of pressure on the screw caused it to pull out of the pedicle.The procedure was completed successfully with the help of another torque handle.There was fifteen to twenty (15-20) minutes of surgical delay occurred.This report is for one (1) 10nm torque limiting ratchet handle-6mm hxc.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: b1, b5, h1: during manufacturer's investigation of the returned device it was identified that the device failed torque testing and was out of calibration.This product condition was evaluated and determined to be reportable on july 20, 2022 d9 h3, h6: a product investigation was conducted.Service and repair evaluation: the customer reported the device had issues in tightening or torqueing the set screws at the end of the case.The repair technician reported device failed torque testing and was out of calibration.The minimum torque peak attained during evaluation was out of the specified limit for the part.Torque test high is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is failed high torque.The item will be forwarded to customer quality.The evaluation was confirmed.H3, h6: a device history record (dhr) review was conducted: part #: 03.620.061 synthes lot #: h892210-07 supplier lot #: h892210-07 release to warehouse date: 21 oct 2020 suppliers: avalign technologies-nemcomed no ncr's generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
During manufacturer's investigation of the returned device it was identified that the device failed torque testing and was out of calibration.This product condition was evaluated and determined to be reportable on july 20, 2022.

• Brand Name: 10NM TORQUE LIMITING RATCHET HANDLE-6MM HXC
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 14886796
• Report Number: 2939274-2022-02459
• Device Sequence Number: 6282880
• Product Code: LXH
• UDI-Device Identifier: 07611819341128
• UDI-Public: (01)07611819341128
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup

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: 03.620.061
• Device Lot Number: H892210-07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/17/2022
• Supplement Date Received by Manufacturer: 07/13/2022; 07/20/2022
• Initial Report FDA Received Date: 07/01/2022
• Supplement Report FDA Received Date: 07/13/2022; 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2020
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PEDIC-SCR-MATR 5.5 Ø6 L45 TAN
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Race: White