MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 15.0MM CANNULATED DRILL BIT LARGE QC/280MM; BIT, DRILL

Catalog Number	03.010.028
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 an open drill bit broke during a lateral entry femoral nail on (b)(6) 2017.The drill bit was reported to have broken as the surgeon was attaching it to the reamer.The part that attaches to the reamer broke off causing an estimated two (2) minute delay in surgery as the surgeon switched over to a new drill bit.The surgery was completed successfully with another drill bit.The patient outcome was reported as perfect.Concomitant devices reported: 3.2 mm guide wire (part 357.399, lot unknown, quantity 1).22.0 mm/17.0 mm protection sleeve (part 357.410, lot unknown, quantity 1).This is report 1 of 1 for (b)(4).

• Brand Name: 15.0MM CANNULATED DRILL BIT LARGE QC/280MM
• 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: 7206334
• Report Number: 2939274-2018-50326
• Device Sequence Number: 764088
• Product Code: HTW
• UDI-Device Identifier: 10886982067029
• UDI-Public: (01)10886982067029(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 12/23/2017

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: 03.010.028
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/23/2017
• Initial Report FDA Received Date: 01/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 20 YR
• Patient Weight: 120