MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SYNFIX EVOL TRIAL IMPLANT HOLDER; TEMPLATE

Catalog Number 03.835.100

Device Problems Device-Device Incompatibility (2919); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2019

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.A review of the device history record has been requested.The investigation could not be completed; 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 Description

Device report from synthes reports an event in australia as follows: it was reported that after procedure, the surgeon tried to remove trial from implant holder.The trial was stuck and could not be removed, the item was tagged.Patient status is unknown.The product investigation will be completed by the investigation team due to the provided images.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

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.Part: 03.835.100.Synthes lot: h119925.Supplier lot: h119925.Release to warehouse date: october 06, 2016.Supplier: (b)(4).No nonconformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.The complaint condition, that the trial was stuck and could not be removed, could not be confirmed according to the received pictures.Product was not returned.Based on the information available, it has been determined that no corrective and 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.

• Brand Name: SYNFIX EVOL TRIAL IMPLANT HOLDER
• Type of Device: TEMPLATE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9013908
• MDR Text Key: 158133054
• Report Number: 8030965-2019-68233
• 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
• Report Date: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• 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: H119925
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2019
• Patient Sequence Number: 1