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

Catalog Number 03.835.100

Device Problem Compatibility Problem (2960)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/06/2021

Event Type  malfunction  

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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the synfix evolution trial medium 15mm would not disengage from the evolution spindle.The trial would unwind to disengage the knob, but the long shaft was stuck at the threaded portion of the spindle.There was no reported surgical delay.There were no fragments generated.The procedure was completed successfully.There was no reported consequence to the patient.Concomitant devices reported: syncage evolution spindle (part number 03.825.002, lot unknown, quantity 1) this report involves one (1) synfix® evolution trial spacer holder.This is report 1 of 2 for (b)(4).

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.D11: additional concomitant devices reported.H6: investigation summary: product was not returned and therefore, no further investigation is possible.Condition of the returned photo prevents proper testing/failure analysis of the reported allegation of "synfix evolution trial medium 15mm 14° will not come off the implant holder and when i was trying to disengage the trial from the evolution spindle that goes down the trial implant holder to engage the trail it would unwind to disengage the knob however the long shaft was stuck at the threaded portion of the spindle".The lot numbers of these instrument are not available.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.

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.Investigation flow: functional/device interaction.Visual inspection: the synfix evol trial implant holder (p/n: 03.835.100, lot number: 9874832) was received at us cq.Visual inspection of the complaint device showed no damage.The complaint device was received disassembled from mating devices.Functional test: a functional assessment was performed on the complaint device and the returned devices.The complaint device was able to assemble with 03.835.224 and would easily disassemble.The 03.825.002 was difficult to assemble with due to the damage on that mating device, but was possible to assemble and disassemble.The complaint was not able to be replicated.Dimensional inspection: a dimensional inspection was not performed since it was not applicable to the complaint condition.Document/specification review: no design issues or discrepancies were identified.The complaint was not confirmed.Investigation conclusion: this complaint is not confirmed as the complaint device was able to assemble and disassemble with the returned mating devices.No definitive root cause could be determined based on the provided 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 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.,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.Device history 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.,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
• Type of Device: TEMPLATE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11235932
• MDR Text Key: 230131095
• Report Number: 8030965-2021-00650
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 07611819682719
• UDI-Public: (01)07611819682719
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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: 05/05/2021
• Date Manufacturer Received: 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SYNCAGE EVOLUTION SPINDLE; SYNCAGE EVOLUTION SPINDLE; SYNFIX EVOL TRIAL IMPLANT HOLDER; SYNFIX EVOLUTION TRIAL IMPL MED H15 14°