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

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/04/2018

Event Type  malfunction  

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 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
• Type of Device: STAPLE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES BME : SAN ANTONIO; 14785 omicron drive; #205; san antonio TX 78245
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7641681
• MDR Text Key: 112571528
• Report Number: 2939274-2018-52646
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00810633020630
• UDI-Public: (01)00810633020630
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DK-265-S
• Device Catalogue Number: DK-265-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1