MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SYNFIX® EVOLUTION TRIAL SPACER HOLDER; TEMPLATE

Catalog Number	03.835.100
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/14/2020
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.Device is not distributed in the united states but is similar to device marketed in the usa.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)(4) as follows: it was reported on an unknown date that the surgeon was used trailed implant but the synfix evolution trial medium height would not come off the trial implant holder.When the nurse was trying to disengage the trial from the evolution spindle that goes down the trial implant holder to engage the trail would unwind to disengage the knob however the long shaft was stuck at the threaded portion of the spindle.The implant trial is stuck onto the implant holder (2-piece instrument) in simpler terms.It could not disengage the trial from the trial holder.There was 30 minutes delay of surgery and completed successfully.There was no patient consequence.This is the report of (1) synfix evol trial implant holder.This is report 01 of 03 of (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).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.
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.Whilst in the case the surgeon as for a different size then the one just trialed and the synfix evolution trial medium 12 height 14° would not come off the trial implant holder.When the nurse was trying to disengage the trial from the evolution spindle that goes down the trial implant holder to engage the trail would unwind to disengage the knob however the long shaft was stuck at the threaded portion of the spindle.The implant trial is stuck onto the implant holder (2 piece instrument) in simpler terms.I had a look at this at the end of the case and i could not disengage the trial from the the trial holder.We have two on the set, therefore the no time was lost in the case.Investigation flow: device interaction/functional.Visual inspection: all three instruments were returned and received at us cq in a disassembled state.Upon visual inspection no issues were noted that would hinder the functionality of this device.Functional test: a functional test was performed with all three instruments and were able to assemble and disassemble as intended.Dimensional inspection: no dimensional inspection was done as no issues were noted during the visual and functional portions of the investigation.Document/specification review: the following drawings were reviewed: disassemble as the portion of the instrument that attaches to the trial spacer is on the distal end and the issue with the handle is on the proximal end and therefore would not affect the functionality of the instrument to interact with the spindle assembly and trial spacer.Based on the review of the above drawings, no design issues contributing to relevant complaint condition were identified.Conclusion: a definitive root cause for this complaint as its unconfirmed.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.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 # 03.835.100, synthes lot # 9874832, supplier lot # 9874832, release to warehouse date: jan 19, 2016, supplier: (b)(4).Nr-0024510 was generated for product overmolded handle is undersized.The 34.4 width of the overmolded handle at print location b-7 is out of specification.This non-conformance is not relevant to the complaint condition as pd and supplier provided justification for use as is.Review of the device history record(s) showed that there were no issues during the manufacture of the product that 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.

• Brand Name: SYNFIX® EVOLUTION TRIAL SPACER HOLDER
• Common Device Name: TEMPLATE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9671155
• Report Number: 8030965-2020-00859
• Device Sequence Number: 2884204
• Product Code: HWT
• UDI-Device Identifier: 07611819682719
• UDI-Public: (01)07611819682719
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/14/2020

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: 03.835.100
• Device Lot Number: 9874832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Initial Date Received by Manufacturer: 01/14/2020
• Supplement Date Received by Manufacturer: 03/10/2020; 03/18/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 03/11/2020; 04/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1