MAUDE Adverse Event Report: SYNTHES GMBH XRL MEDIUM TORQ LIMIT HAND; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	03.807.357
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that the item was found to be out of tolerance when doing an on site test.Event did not involve any patient.
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.H.11.Additional narrative: added: d9.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.
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.H11 additional narrative: h3, h4, h6: the product was returned to j&j medtech orthopaedics for evaluation.The j&j medtech orthopaedics team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that there were no damage or defect with the xrl medium torq limit hand.A dimensional inspection for the xrl medium torq limit hand was not performed as it is not applicable to the complaint condition.A functional test was attempted to do with adaptor number for connection to meter ft061496 and the adapter could not be connected correctly to the torque as the adapter was press and the audible ¿click¿ is not heard, possibly due to some damage to the connection mechanism.A potential reason for this condition can be traced to a possible damage of the internal components of the locking mechanism.However, due to the inability to access these internal components without damaging the device, this remains unknown, and the complete potential cause not established.Per the xrl vertebral body replacement device surgical technique guide se_862967 rev.Ab 3.Attach endplate screws.Align the endplate screwdriver tip into the open end of the torque limiting handle.Press until an audible ¿click¿ is heard.Align the tri-lobal feature of the tip and the etchings on the endplate screw.Lightly press the screw onto the screwdriver tip.The screwdriver tip will retain the screw.Align the torque limiting handle with the central body to prevent cross threading.While gripping the large end of the torque limiting handle, rotate the torque limiting handle clockwise to advance the screw through the caudal endplate and into the central body.Tighten until an audible ¿click¿ in the torque limiting handle is heard.Repeat this step to fixate the cranial endplate.Follow torque limiting handle calibration instructions to ensure proper functionality.The overall complaint was confirmed as the observed condition of the xrl medium torq limit hand would contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.As part of j&j medtech orthopaedics quality process, all devices ar manufactured, inspected, and released to approved specifications.There is no indication that a design or manufacturing issue has caused the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review: product code: 03.807.357, lot number: 1458, release to warehouse date: 09.Mar.2022, manufacturing site: werk pt & c ch3d.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: XRL MEDIUM TORQ LIMIT HAND
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 22954205
• Report Number: 8030965-2025-08943
• Device Sequence Number: 20897985
• Product Code: LXH
• UDI-Device Identifier: 07611819419070
• UDI-Public: (01)07611819419070(10)1458
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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: 03.807.357
• Device Lot Number: 1458
• 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: 08/15/2025
• Supplement Date Received by Manufacturer: 09/10/2025; 10/08/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 09/11/2025; 10/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2022
• 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
• Patient Sex: Unknown