MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.0MM DRILL BIT/K-WIRE ATTCHMT FOR THREADED HOLE/75MM

Model Number	03.130.100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Additional narrative: 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 as no product was received.The investigation could not be completed, and no conclusion could be drawn at the time of filing this report.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 on (b)(6) 2021, the patient underwent an unknown procedure using variable angle handset.During the procedure, while surgeon was using a drill bit through a locking plate (va handset) on a proximal phalanxe, the drill bit broke.The fragment was removed.The surgeon retrieved the fragment and the surgery was completed successfully with a five (5) minute surgical delay.The patient's status is unknown.Concomitant device reported: unknown 1.3 locking plate (part#: unknown, lot#: unknown, quantity: 1) this complaint involves one (1) device.This report is for (1) 1.0mm drill bit/k-wire attchmt for threaded hole/75mm this report is 1 of 1 (b)(4).

• Brand Name: 1.0MM DRILL BIT/K-WIRE ATTCHMT FOR THREADED HOLE/75MM
• Common Device Name: DRILL BIT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11508520
• Report Number: 2939274-2021-01375
• Device Sequence Number: 3997546
• Product Code: HTW
• UDI-Device Identifier: 10886982075215
• UDI-Public: (01)10886982075215
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/18/2021

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: 03.130.100
• Device Catalogue Number: 03.130.100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 03/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1