MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.3MM DRILL BIT/QC/180MM; BIT,DRILL

Catalog Number	310.431
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient date of birth/age, sex and weight were not provided for reporting.Device is an instrument and is not implanted / explanted.Device is not expected to be returned for manufacturer review/investigation.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.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 on (b)(6) 2017, the patient underwent surgery of proximal tibia repair.During the surgery, while drilling with the 4.3mm blue drill bit broke inside the patient.A tissue protector was being used at the time.A portion of the drill bit is still inside patient.Staff could retrieve piece of drill bit with forceps.An x-ray was taken after retrieving the leftover drill bit piece, revealing all drill fragments were removed.The procedure was successfully completed.There was a delay of a few minutes to take the broken piece out of the patient.There was no harm to the patient.Patient outcome was reported as fine.Concomitant device reported.Screwdriver (part# unknown, lot# unknown, quantity 1).This report is for one (1) 4.3mm drill bit/qc/180mm.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
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
Concomitant device reported: tissue protector (part# unknown, lot# unknown, quantity (b)(4)).

• Brand Name: 4.3MM DRILL BIT/QC/180MM
• 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: 7118596
• Report Number: 2939274-2017-50279
• Device Sequence Number: 1298850
• Product Code: HTW
• UDI-Device Identifier: 10886982186638
• UDI-Public: (01)10886982186638(10)LOT#UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2017

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: 310.431
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2017
• Supplement Date Received by Manufacturer: 12/28/2017
• Initial Report FDA Received Date: 12/14/2017
• Supplement Report FDA Received Date: 01/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1