MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.7MM CANNULATED DRILL BIT/QC 100MM; BIT,DRILL

Catalog Number	310.215
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.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 when using 2.4mm cannulated screw set and drilling over a 0.8mm guide wire and taking drill bit out after drilling, it was noticed that the tip of the drill bit had broken off.Fragments of the drill bit were left in patient.Also during this foot procedure, one of the 0.8mm guide wires was bent during insertion of a screw.The bent guide wire was taken out and replaced with a new one.There was 5-7 minutes delay in the surgery.Procedure was completed successfully.Patient status reported as stable.Concomitant devices reported: 2.4mm cannulated screw (part 211.820, lot number unknown, quantity 1) this report is for one (1) 1.7mm cannulated drill bit this is report 1 of 2 for (b)(4).

• Brand Name: 1.7MM CANNULATED DRILL BIT/QC 100MM
• 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: 7379842
• Report Number: 2939274-2018-51294
• Device Sequence Number: 1657561
• Product Code: HTW
• UDI-Device Identifier: 10886982186225
• UDI-Public: (01)10886982186225(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 02/28/2018

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: 310.215
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 03/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR
• Patient Weight: 95