MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC XRL LARGE TORQUE LIMITING HANDLE; MISC ORTHO SURGICAL INSTR

Model Number	03.807.358
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: (b)(6).The device has been 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.
Event or Problem Description
It was reported on (b)(6) 2020, during evaluation, the repair technicians found that an expandable radiolucent vertebral body replacement system (xrl) large torque limiting handle failed calibration.There was no patient involvement.This report involves one (1) xrl large torque limiting handle.This is report 1 of 1 for (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.H3, h4, h6: the device shows no physical damage.The overall device appeared to be in good shape.The overall complaint was confirmed for the received xrl large torque limiting handle.Although no definitive root-cause can be determined its possible an internal mechanical failure resulted due to unintended forces.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: part #: 03.807.358, synthes lot number: 1108, supplier lot number: 1108, manufacturing site: synthes monument, release to warehouse date: 18-apr-2013, supplier: gmbh.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.
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.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.

• Brand Name: XRL LARGE TORQUE LIMITING HANDLE
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10074756
• Report Number: 2939274-2020-02459
• Device Sequence Number: 3358502
• Product Code: LXH
• UDI-Device Identifier: 10705034723310
• UDI-Public: (01)10705034723310
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/07/2020

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 Model Number: 03.807.358
• Device Catalogue Number: 03.807.358
• Device Lot Number: 1108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2020
• Initial Date Received by Manufacturer: 05/07/2020
• Supplement Date Received by Manufacturer: 05/27/2020; 06/05/2020
• Initial Report FDA Received Date: 05/20/2020
• Supplement Report FDA Received Date: 06/05/2020; 06/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1