MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SYNFIX EVOL TRIAL IMPLANT 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	11/01/2019
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.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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported on (b)(6) 2019, at the end of the case, i was packing up the set and the synfix evolution trial m 13.5 10 degree would not come off the trial implant holder.When i was trying to disengage the trial 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 threader portion of the spindle.The implant trial is stuck onto the implant holder (2 pieces instrument) in simpler terms.No patient consequence.This complaint involves two (2) devices.This is 1 of 2 for report (b)(4).

• Brand Name: SYNFIX EVOL TRIAL IMPLANT HOLDER
• Common Device Name: TEMPLATE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9437314
• Report Number: 8030965-2019-70911
• Device Sequence Number: 3623066
• 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
• Report Date (Section B): 11/19/2019

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 12/09/2019
• Patient Sequence Number: 1