MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.5MM DRILL BIT W/DEPTH MARK STRYKER J-LATCH/110MM; INSTR,SURGICAL,ORTHOPEDIC,AC-POWERED MOTOR/ACCESS & ATTACH

Catalog Number	310.161
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is an instrument and is not implanted/explanted.It is unknown if the device is returning 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 that on (b)(6) 2018, patient underwent an unknown orthopedic procedure.During the procedure, the 1.5mm drill bit broke.The fragment was completely removed.It is unknown if there was a back-up similar device for the surgeon to successfully complete the procedure.It is unknown if this malfunction resulted in surgical delay.Reportedly, there was no patient consequences.Concomitant device reported: drill (part# unknown, lot# unknown, quantity 1).This report is for one (1) 1.5mm drill bit w/depth mark stryker j-latch/110mm.This is report 1 of 1 for (b)(4).
Event or Problem Description
There was no patient harm.
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.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: 1.5MM DRILL BIT W/DEPTH MARK STRYKER J-LATCH/110MM
• 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 PA 19380
• MDR Report Key: 7288932
• Report Number: 2939274-2018-50720
• Device Sequence Number: 16485877
• Product Code: HWE
• UDI-Device Identifier: 10886982186089
• UDI-Public: (01)10886982186089(10)LOT#UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 01/26/2018

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: 310.161
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/26/2018
• Supplement Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 02/22/2018
• Supplement Report FDA Received Date: 03/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1