MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0MM DRILL BIT/QC/125MM; INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH

Catalog Number	310.21
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patients height reported as 5 feet 4 inches.Additional device product codes: hsz, gfa, gff.Device is an instrument and is not implanted/explanted.Complainant device 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 the tip of the drill bit broke off during a distal radius fracture procedure on (b)(6) 2017.All fragments were retrieved.A new drill bit was used to successfully complete the surgery with no delay.The patient outcome was reported as good.This report is for one (1) 2.0mm drill bit/qc/125mm.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Corrected data: reported lot number h480407 is incorrect.Lot number is not legible on the device, therefore lot number is unknown.Udi number.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.

• Brand Name: 2.0MM DRILL BIT/QC/125MM
• Common Device Name: INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester 19380
• MDR Report Key: 7101245
• Report Number: 2939274-2017-50193
• Device Sequence Number: 1934263
• Product Code: HWE
• UDI-Device Identifier: 10886982186188
• UDI-Public: (01)10886982186188(10)H480407
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/10/2017

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: 310.21
• Device Lot Number: H480407
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/10/2017
• Supplement Date Received by Manufacturer: 12/13/2017
• Initial Report FDA Received Date: 12/08/2017
• Supplement Report FDA Received Date: 01/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 80