MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.2MM DRILL BIT/JC/130MM; INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH

Catalog Number	310.32
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product codes: gff, gfa, hsz device is an instrument and is not implanted/explanted.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.Investigation summary: dhr review could not be conducted due the insufficient information¿s.Product was not returned and no lot number was provided.Based on the information available, 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.
Event or Problem Description
It was reported that during a total knee replacement procedure on (b)(6) 2018, the tip of one (1) 3.2 mm drill bit broke into two pieces inside the bone and was later found and retrieved.While the surgeon was using the drill bit through the cutting guide for the knee replacement, somehow the surgeon flexed the patient's knee and the tip of the drill bit broke.The broken tip was found and retrieved.It is unknown if another drill bit was available for use, but the procedure was reported to have been completed successfully with no surgical delay.The patient was reported to be in stable condition.This complaint involves one (1) device.Concomitant devices reported: unknown drill (part# unknown, lot# unknown); unknown knee prosthesis (part# unknown, lot# unknown, quantity# 1).This report is 1 of 1 for (b)(4).

• Brand Name: 3.2MM DRILL BIT/JC/130MM
• 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: 7401637
• Report Number: 2939274-2018-51490
• Device Sequence Number: 13820630
• Product Code: HWE
• UDI-Device Identifier: 10886982186492
• UDI-Public: (01)10886982186492(10)LOTUNK
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 03/12/2018

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: 310.32
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/12/2018
• Initial Report FDA Received Date: 04/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 108