MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 17.0MM CANNULATED DRILL BIT LARGE QC/300MM; BIT,DRILL

Catalog Number	357.394
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Device history records review pending completion.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 on (b)(6) 2017, patient underwent a trochanteric fixation nail (tfn) procedure.During the procedure, the opening drill bit snapped at the quick connect attachment.It was chucked on a stryker system 7 drill.Drill bit was removed and the awl was used to complete entry.Generated fragments were removed easily.There was no patient consequence.The procedure was completed successfully with no delay.Patient status was reported as good.This report is for one (1) 17.0mm cannulated drill bit large qc/300mm.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: device available for evaluation: date returned to manufacturer.Subject device has been received and is currently in the evaluation process.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
Device was used for treatment, not diagnosis.A product development investigation was performed for the subject device (drill bit, part number 357.394, lot number ur68798).The subject device was returned with the complaint condition stating the complaint of broken was confirmed.Whether this complaint could be replicated is not applicable because the device was returned broken.Upon visual inspection, it was noted that the drill bit was broken at the transition between the 8mm and 6 mm diameter sections.The fragment was not returned.Dimensional analysis was not performed as relevant features were not returned.Drawings were reviewed and were determined to be suitable for the intended design, application and dimensional conformity when used as recommended.Dhr review showed no ncr¿s were generated during production.Material and hardness testing was completed at the time of manufactured and confirmed to have no issues through the dhr review.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition, based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.While no definitive root cause could be determined it is possible that the device encountered unintended forces (such as being struck off axis).Device history record review.Part number: 357.394, synthes lot number: ur68798, release to warehouse date: 19-mar-2007, 28-mar-2007, supplier: (b)(4).Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which 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.

• Brand Name: 17.0MM CANNULATED DRILL BIT LARGE QC/300MM
• Common Device Name: BIT,DRILL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7154614
• Report Number: 2939274-2017-50491
• Device Sequence Number: 1979379
• Product Code: HTW
• UDI-Device Identifier: 10886982196194
• UDI-Public: (01)10886982196194(10)UR68798
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/02/2017

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: 357.394
• Device Lot Number: UR68798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Initial Date Received by Manufacturer: 12/02/2017
• Supplement Date Received by Manufacturer: 01/19/2018; 01/29/2018
• Initial Report FDA Received Date: 12/29/2017
• Supplement Report FDA Received Date: 01/25/2018; 01/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR