MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 12.0MM CANNULATED DRILL BIT LARGE QC/190MM; BIT, DRILL

Catalog Number	03.010.036
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: patient information is unknown.Unknown date in 2017.Device is an instrument and is not implanted/explanted.Facility phone number was not provided.(b)(4).The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 during tibial nail ex opening procedure, drill bit quick connect broke apart from opening reamer.There was no delay in the procedure and procedure was completed successfully.Patient was reported as stable.Concomitant devices reported: non-synthes drill bit (part/lot unknown, quantity 1).(b)(4).
Additional Manufacturer Narrative
Additional narrative: device history records review was completed for part# 03.010.036, lot# pe00805.Supplier: (b)(4), release to warehouse date: dec 28, 2010, jan 06, 2011 and jan 26, 2011.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.Product development investigation was completed.The returned drill bit (part 03.010.036, lot pe00805, mfg.28-dec-2010) was inspected at customer quality and the complaint 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 had broken at the transition between the 6 mm and 8 mm section based on drawing.Broken piece was not returned.Relevant drawings were reviewed and no design issues were identified.Dimensional analysis was completed, the inner diameter of the proximal end, measured 3.83 mm (gauge pins gp32).This is within specification of 3.60 to 3.90 mm, based on drawing.While no definitive root cause could be determined it is possible that the device encountered unintended forces (such as being bent/torqued beyond its capabilities, struck off axis or damaged during sterile processing).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.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: 12.0MM CANNULATED DRILL BIT LARGE QC/190MM
• 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: 7207002
• Report Number: 2939274-2018-50331
• Device Sequence Number: 1174224
• Product Code: HTW
• UDI-Device Identifier: 10886982067098
• UDI-Public: (01)10886982067098(10)PE00805
• 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): 12/26/2017

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: 03.010.036
• Device Lot Number: PE00805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Initial Date Received by Manufacturer: 12/26/2017
• Supplement Date Received by Manufacturer: 02/21/2018
• Initial Report FDA Received Date: 01/19/2018
• Supplement Report FDA Received Date: 02/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1