MAUDE Adverse Event Report: SYNTHES GMBH XRL MEDIUM SPREADER TOP WITH 8MM DISTRACTION; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number	03.807.313
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2022
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.Therapy date: (b)(6) 2022.The subject 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 switzerland as follows: it was reported that on (b)(6) 2022, during the preparation for implantation of a xrl cage, the assembly of the implant holder and it was noticed that the xrl release tool did not hold tight in the shaft and the tactile feedback of the resting position and the end position was very weak.After connecting to the implant, the implant was expanded for test over the back table (not in situ).It was then noticed that the release tool was slipping back out of the shaft and had to be hold in place by hand.As the implant had to be collapsed, it was not possible (handle on of, release tool in place) to turn the handle counterclockwise and collapse the implant.There was a surgical delay of 10 minutes.A second implant was unwrapped an implanted with constant pressure on the release tool.The procedure was completed successfully.There were no patient consequences.This report involves one (1) xrl medium spreader top with 8mm distraction.This is report 4 of 4 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.H10 additional narrative: investigation summary: the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the xrl medium spread top straig distrac wid, p/n: 03.807.313 was returned in an assembled condition.No significant product problems were observed on the surface of the device.A dimensional inspection was unable to be performed due to device design.A functional test was performed and it revealed that it was not possible to disassemble the device from the returned xrl medium shaft straig f/03.807.300, p/n: 03.807.310.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the xrl medium spread top straig distrac wid, p/n: 03.807.313 would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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 # 03.807.313.Lot # 8504929.Manufacturing site: werk hagendorf.Release to warehouse date: 16 oct 2013.Expiration date: n/a.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.

• Brand Name: XRL MEDIUM SPREADER TOP WITH 8MM DISTRACTION
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15248332
• Report Number: 8030965-2022-05835
• Device Sequence Number: 6493707
• Product Code: MQP
• UDI-Device Identifier: 07611819406148
• UDI-Public: 07611819406148
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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: 03.807.313
• Device Lot Number: 8504929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2022
• Supplement Date Received by Manufacturer: 08/24/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 08/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2013
• 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: XRL MEDIUM INTEGR H28-36 0°.; XRL MEDIUM SHAFT STRAIG F/03.807.300.; XRL RELEASE TOOL F/03.807.300.; XRL SPREADER.
• Patient Sex: Unknown