MAUDE Adverse Event Report: SYNTHES GMBH XRL RELEASE TOOL; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	03.807.348
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a synthes employee.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
Device report from synthes reports an event in the (b)(6) as follows: it was reported that on an unknown date, the instrument was difficult to work with and became stuck.The issue was discovered prior to a procedure.This report involves one (1) xrl release tool.This is report 2 of 3 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.H3, h4, h6: part 03.807.348, lot 8910006: manufacturing site: hagendorf.Release to warehouse date: may 26, 2014.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.H3, h6: a product investigation was competed: upon visual inspection, there was no issues were observed with the returned device.A functional assessment was performed on the complaint device with the relevant mating devices.The devices were able to disassemble and assemble without any issues.Also, the locking mechanism worked as intended.The retaining collar retracted properly.No implant was received with the complaint devices.A dimensional inspection was not performed as the internal components were inaccessible without destruction of the device.Based on the date of manufacture, the current and manufactured revision of drawings were reviewed; no design issues or discrepancies were identified.The complaint was not confirmed as the device worked as intended.There was no indication that a design or manufacturing issue contributed to the complaint.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 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 RELEASE TOOL
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12361397
• Report Number: 8030965-2021-07138
• Device Sequence Number: 3811885
• Product Code: MQP
• UDI-Device Identifier: 10705034723242
• UDI-Public: (01)10705034723242
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K103320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2021

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: 03.807.348
• Device Catalogue Number: 03.807.348
• Device Lot Number: 8910006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2021
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 09/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1