MAUDE Adverse Event Report: SYNTHES HAGENDORF DRILL/TAP AND SCREW GUIDE WITH POST

Catalog Number	03.613.001
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.No patient involvement reported.Device is an instrument and is not implanted/explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.Device history records review was conducted.The report indicates that the: part 03.613.001, lot 9479627.Manufacturing site: (b)(4).Manufacturing date: 04 sep.2015.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition 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
It was reported that the following instruments were discovered to be malfunctioning: two screw inserters t8 self-retaining/qc are not self-retaining screws any longer (the devices were tried with unknown screws).The lid locking mechanism on one module for ti zero-p va screws is broken -not functioning properly/not holding the screws in any longer.Four insertion screwdrivers self-retaining are not self-retaining screws any longer (the devices were tried with unknown screws).And one drill tp/screw guide with post looks as if it is slightly bent.This was identified when sets were inspected in sterile processing.No procedure or patient involvement.This complaint involves one device.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
A product investigation was completed: the bent complaint condition was able to be confirmed.One of the distal phalanges of the dts guide was very slightly bent inwards.A visual inspection, functional test, device history records review, and drawing review were performed as part of this investigation.The relevant product drawings were reviewed.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.A device history review was performed for the returned instruments¿ lot number and no material review reports, non-conformance reports or complaint-related issues were identified with the lot numbers which may have contributed to the complaint condition.A root cause could not be determined for the screw module and the dts guide as the circumstances at the time of use are unknown.During the investigation no product design issues or discrepancies were observed that may have contributed to the 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.
Event or Problem Description
The malfunctions for all of the parts were assessed and it was determined only the bent drill/tap and screw guide with post met the criteria of a reportable event.

• Brand Name: DRILL/TAP AND SCREW GUIDE WITH POST
• Common Device Name: GUIDE
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 6531196
• Report Number: 3003875359-2017-10204
• Device Sequence Number: 1268873
• Product Code: FZX
• UDI-Device Identifier: 10705034714547
• UDI-Public: (01)10705034714547(10)9479627
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2017

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: 03.613.001
• Device Lot Number: 9479627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/06/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/28/2017
• Supplement Report FDA Received Date: 05/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1