MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TEMPORARY FIXATION PIN; GUIDE

Catalog Number	324.101
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional patient id (b)(6).Patient weight was not provided for reporting.Device is an instrument and is not implanted / explanted.Device is expected to be returned for manufacturer review/investigation, but has not been received yet.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review could not be completed without lot number.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 europe reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, patient underwent an anterior cervical discectomy and fusion surgery.During the surgery, an extraction screwdriver and the temporary fixation pin broke.Bone wax was used with vectra removal screw driver to complete the surgery.There was a 15 minutes surgical delay.Surgery was completed successfully.Patient outcome was not reported.This report is for one (1) temporary fixation pin.This is report 2 of 2 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.Pre-investigation statement: as described in the complaint description it was reported that during a procedure, the fixation pin broke.The returned part was found in an undamaged condition and therefore the flow chart number 4 (visual) was selected for this investigation.Investigation selection: investigation site: cq zuchwil; selected flow(s): 4.Visual | examples: missing feature or component/peeling coating/corrosion/temperature sensitive indicator visual inspection: upon visual inspection of the complaint device it can be seen that it's in an undamaged condition.In addition, it's clearly visible that the missing part (broken off) from the article 352.311 screwdriver stuck in the pin thread.Document/specification review: could not be conducted due the insufficient information, missing lot number.(lot number isn't etched on the part) dimensional inspection: could not be conducted due the insufficient information, missing lot number.(lot number isn't etched on the part) summary: complained issue could not be replicated and/or confirmed based on the returned part.The returned part was found in an undamaged condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.The subject device has been received and the product evaluation is in progress.No conclusion can be drawn.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: TEMPORARY FIXATION PIN
• Common Device Name: GUIDE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7707125
• Report Number: 8030965-2018-55183
• Device Sequence Number: 10945649
• Product Code: FZX
• UDI-Device Identifier: 10705034769325
• UDI-Public: (01)10705034769325
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 06/30/2018

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: 324.101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Initial Date Received by Manufacturer: 06/30/2018
• Supplement Date Received by Manufacturer: 07/23/2018; 09/10/2018
• Initial Report FDA Received Date: 07/20/2018
• Supplement Report FDA Received Date: 08/06/2018; 09/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR