MAUDE Adverse Event Report: SYNTHES HAGENDORF 2.0MM THREADED DRILL GUIDE WITH DEPTH GAUGE

Catalog Number	323.061
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: device is an instrument and is not implanted / explanted.Device history records review was completed for part # 323.061, lot # 1974626.Manufacturing location: (b)(4), manufacturing date: aug 27, 2008.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The device was 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.
Event or Problem Description
It was reported that three devices malfunctioned during a distal radius procedure on (b)(6) 2017.The threaded drill guide would not thread into the plate properly and was wobbly.Two screwdriver shafts would not self-retain screws.The procedure was successfully completed with other instruments with no delay.The patient outcome was reported as fine with no issues.Concomitant devices reported: plate (part # unknown, lot # unknown, quantity 1); screws (part # 210.1xx, lot # unknown, quantity 2).This report is for one (1) 2.0mm threaded drill guide with depth gauge.This is report 1 of 3 for (b)(4).
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Additional narrative: a product development investigation was performed for the subject device 2.0mm threaded drill guide with depth gauge, part number 323.061, lot number 1974626).The subject device was returned with the complaint condition stating: this complaint is confirmed for the threaded drill guide but not confirmed for the 2 screwdriver blades.The threaded drill guide has malformed distal threadform (post manufacturing damage).The distal most threadform has a dent that could prevent it from functioning as intended.The 2 returned screwdriver blades show minor wear but no damage that would prevent function.The complaint conditions for the returned devices were not able to be replicated at customer quality (cq) because the concomitant screws and plate involved in the event were not returned to cq.A visual inspection under 5x magnification, device history record (dhr) review and drawing review were performed as part of this investigation.Part 1 of 3 part # 323.061 2.0mm threaded drill guide with depth gauge visual inspection: the distal male threadform has a nick/dent on the distal most thread that could prevent this 8+ year old reusable instrument from functioning as intended.Drawings were reviewed during this investigation.No product design issues or discrepancies were observed.Part 2 of 3 part # 314.467 stardrive screwdriver shaft t8105mm.Visual inspection: the distal tip shows minor wear consistent with usage.No damage that would prevent function was observed under 5x magnification.Drawing review: drawing was reviewed during this investigation.No product design issues or discrepancies were observed.Part 3 of 3 part # 314.453 stardrive screwdriver shaft t855mm.Visual inspection: the distal tip shows minor wear consistent with usage.No damage that would prevent function was observed under 5x magnification.Drawing review: drawings were reviewed during this investigation.No product design issues or discrepancies were observed.Most likely due to cumulative wear for this 8+ year old reusable instrument.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2.0MM THREADED DRILL GUIDE WITH DEPTH GAUGE
• Common Device Name: GUIDE
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 6412925
• Report Number: 3003875359-2017-10125
• Device Sequence Number: 31326
• Product Code: FZX
• UDI-Device Identifier: 10886982190741
• UDI-Public: (01)10886982190741(10)1974626
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 02/24/2017

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: Physician
• Device Catalogue Number: 323.061
• Device Lot Number: 1974626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/24/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2017
• Supplement Report FDA Received Date: 04/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ONE (1) UNKNOWN PLATE; TWO (2) UNKNOWN SCREWS