MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPEED SHIFT/TITAN DRILL KIT S-265QD; STAPLE, FIXATION, BONE

Model Number	DK-265-S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is unknown.Lot number is unknown.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter email address is unknown.Without a lot number the device history records review could not be completed.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 a podiatry procedure on (b)(6) 2018, the drill bit from the 2.65mm drill kit (dk) broke.While using the sterile drill kit to implant bme speed titan staples, the drill bit in the kit broke into two pieces while the doctor was drilling.Both fragments were easily recovered without additional medical intervention and the doctor was able to proceed with the procedure by opening another sterile 2.65 mm drill kit.The procedure was completed successfully without surgical delay.Patient outcome was stable.This report is for a speed shift/titan drill kit s-265qd.This is report 1 of 1 for (b)(4).

• Brand Name: SPEED SHIFT/TITAN DRILL KIT S-265QD
• Common Device Name: STAPLE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7641681
• Report Number: 2939274-2018-52646
• Device Sequence Number: 11237510
• Product Code: JDR
• UDI-Device Identifier: 00810633020630
• UDI-Public: (01)00810633020630
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K133780
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/05/2018

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 Model Number: DK-265-S
• Device Catalogue Number: DK-265-S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 06/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1