MAUDE Adverse Event Report: SYNTHES BETTLACH 2.8MM CALIBRATED DRILL BIT QC 250MM/95MM; BIT,DRILL

Catalog Number	03.113.024
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information is not available for reporting.Device is an instrument and is not implanted/explanted.Device is not expected to be returned for manufacturer review/investigation.(b)(4).A device history record (dhr) review was performed on the part # 03.113.024, lot # 9126775: manufacturing location: bettlach, manufacturing date: 27.Aug.2014.No non conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 surgery for a tibia fracture on (b)(6) 2017 using a tibia intramedullary (im) nail, with one (1) 3.5mm variable angle (va) proximal tibia plate/ screws to reduce the fracture the drill bit broke.After the surgeon had implanted the im nail, and was preparing for the plate/screw implantation, as he was drilling the pilot screw hole thru the (va) plate and into the tibia bone, he noted that he had engaged the previously implanted im nail and broke the tip of the drill bit.Additional images were taken to identify the location of the broken tip.Tip fragment was easily removed.Due to this event and additional 5 minutes was added to operating room time.Surgery was completed successfully, and patient is reported in stable condition.Concomitant devices reported: tibia intramedullary (im) nail (part # unknown, lot # unknown, quantity 1), 3.5mm variable angle (va) proximal tibia plate, (part # unknown, lot # unknown, quantity 1), locking screws (part# unknown, lot # unknown, quantity unknown) this is report 1 of 1 for complaint com-(b)(4).

• Brand Name: 2.8MM CALIBRATED DRILL BIT QC 250MM/95MM
• Common Device Name: BIT,DRILL
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• MDR Report Key: 6411058
• Report Number: 9612488-2017-10118
• Device Sequence Number: 13464765
• Product Code: HTW
• UDI-Device Identifier: 10886982072900
• UDI-Public: (01)10886982072900(10)9126775
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.113.024
• Device Lot Number: 9126775
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2017
• Initial Report FDA Received Date: 03/16/2017
• 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: LOCKING SCREWS(ITEM AND LOT # UNKNOWN, QTY UNK); PROXIMAL TIBIA PLATE(PART AND LOT # UNKNOWN, QTY 1; TIBIA IM NAIL (PART AND LOT # UNKNOWN, QTY 1)
• Outcome Attributed to Adverse Event: Required Intervention