MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.1 DRILL BIT/K-WIRE ATTCHMT THRD H/70; BIT, DRILL

Model Number	03.130.200
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer 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.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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 drill bit broke and flew out of the handpiece while the scrub tech was holding it to clean it.Scrub tech accidentally turned on the drill and it's a high-speed handpiece.There was no drill guide attached at the time causing the drill bit to spin rapidly and bend, which caused the drill bit to break.It then ejected from the handpiece, hit the overhead light fixture above the patient, ricocheted off there, and hit my head.The puncture in my scalp is the diameter of the drill bit, 1.1 mm.Procedure was completed successfully without any surgical delay.Concomitant device reported: unk - drill (part#: unknown, lot#: unknown, quantity#:1 ).Unk - powered drivers/handpieces (part#: unknown, lot#: unknown, quantity#:1).This report is for one (1) 1.1 drill bit/k-wire attchmt thrd h/70.(b)(4).

• Brand Name: 1.1 DRILL BIT/K-WIRE ATTCHMT THRD H/70
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK SYNTHES UMKIRCH (DE); im kirchenhürstle 4-6; umkirch bei freiburg 79224 ; GM 79224
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12899105
• Report Number: 2939274-2021-06862
• Device Sequence Number: 19839597
• Product Code: HTW
• UDI-Device Identifier: 10886982075314
• UDI-Public: (01)10886982075314
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/02/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 03.130.200
• Device Catalogue Number: 03.130.200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - DRILL; UNK - DRILL BITS: TRAUMA; UNK - POWERED DRIVERS/HANDPIECES
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 100 KG