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

Catalog Number	03.807.300
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2021, intraoperatively a small spring internally got broken or misaligned and was captured inside the extender.The function of the instrument became uncomfortable without the ratchet function, but positioning and locking the xrl implant was performed safe and fast.The cage needed to be secured by hand because the locking mechanism did not work anymore.Procedure was completed successfully without any surgical delay.This report is for one (1) xrl spreader.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.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.
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: d4, d7, g2, h3, h4, h6: part: 03.807.300, lot: 8591631, release to warehouse date: august 30, 2013, manufacturer: hagendorf.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the xrl spreader was returned and received at us customer quality (cq).Upon visual inspection at cq, there were no issues were observed with the returned device.No signs of any breakage were noted.Functional test: a functional assessment was performed on the complaint device.The ratcheting mechanism of the body was noted to be loose and not locking in position.The ball plunger was then tightened using a flat head screwdriver.The ratcheting mechanism now worked as intended, locking into position.The device was able to disassemble and assemble without any issues after the tightening of the ball plunger.Dimensional inspection: a dimensional inspection was not performed as the internal components were inaccessible without destruction of the device.Document/specification review: the following drawings (current and manufactured to) were reviewed.Spreader synex radiolucent, body synex rl spreader, ball plunger, m4 x9mm (source controlled drawing), no design issues or discrepancies were identified.Investigation conclusion: the overall complaint is confirmed as the ball plunger was found to be loose affecting the ratcheting mechanism.Upon tightening of the ball plunger, the device functioned as intended.There were no signs of any breakage noted.A root cause for the reported complaint condition cannot be determined with the available information.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 SPREADER
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12698794
• Report Number: 8030965-2021-08988
• Device Sequence Number: 17169636
• Product Code: MQP
• UDI-Device Identifier: 07611819406100
• UDI-Public: (01)07611819406100
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 10/14/2021

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 Catalogue Number: 03.807.300
• Device Lot Number: 8591631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2021
• Supplement Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 10/26/2021
• Supplement Report FDA Received Date: 01/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2013
• 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
• Patient Sex: Unknown