MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SYNFIX® EVOLUTION TRIAL SPACER MED/12MM HEIGHT/14°; TEMPLATE

Catalog Number	03.835.222
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is company representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; 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 (b)(6) as follows: it was reported on an unknown date that the patient was underwent for an anterior lumbar interbody fusion on an unknown date.During the surgery the medium synfix evolution trail is threaded and will not load into the trial holder.The trial was removed from holder at the end of the case.The procedure was completed successfully without delay.There were no patient consequences.Concomitant devices reported: unknown holder (part# unknown, lot# unknown, quantity# 1).This complaint involves one (1) device.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.H6: based on the inspection by the local technician it is determined that the reusable instrument is worn from repeated use and service.The complaint is therefore rated as confirmed.Product was not returned to the analysis site because the customer requested the device back, therefore no further investigation is possible.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.H3, h4, h6: a device history record (dhr) review was conducted: part: 03.835.222, lot: 9545219, manufacturing site: hägendorf, release to warehouse date: 10.Sep.2015.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: SYNFIX® EVOLUTION TRIAL SPACER MED/12MM HEIGHT/14°
• Common Device Name: TEMPLATE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10047573
• Report Number: 8030965-2020-03408
• Device Sequence Number: 14292212
• Product Code: HWT
• UDI-Device Identifier: 07611819680944
• UDI-Public: (01)07611819680944
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2020

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 Catalogue Number: 03.835.222
• Device Lot Number: 9545219
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/28/2020
• Supplement Date Received by Manufacturer: 05/27/2020
• Initial Report FDA Received Date: 05/12/2020
• Supplement Report FDA Received Date: 06/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SYNFIX EVOLUTION TRIAL IMPL MED H12 14°; UNK - INSERTION INSTRUMENTS; UNK - INSERTION INSTRUMENTS