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 Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional narrative: patient weight is unknown.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.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 a 1.7mm cannulated drill bit broke during a podiatric procedure on (b)(6) 2018.As the bit was passed over the guide wire after measuring for the cannulated screw, the bit broke and a portion was left in the patient.The procedure was completed successfully and without further incident.That patient outcome was reportedly satisfactory.No delay in operating room time was reported.Concomitant devices: cannulated screw (part/lot unknown, quantity 1); guide wire (part/lot unknown, quantity 1).(b)(4).
Additional Manufacturer Narrative
Device history records review was completed for part# 310.215, lot# pe02339, supplier lot number: (b)(4), supplier: (b)(4), release to warehouse date: aug 20, 2015, expiry date: n/a.No non- conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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.

• 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: 7263284
• Report Number: 2939274-2018-50587
• Device Sequence Number: 13910079
• Product Code: HTW
• UDI-Device Identifier: 10886982186225
• UDI-Public: (01)10886982186225(10)PE02339013
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2018

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
• Device Lot Number: PE02339013
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/19/2018
• Supplement Date Received by Manufacturer: 03/20/2018
• Initial Report FDA Received Date: 02/12/2018
• Supplement Report FDA Received Date: 03/20/2018
• 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: 57 YR