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

Model Number	310.21
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional procode: hsz, gfa, gff 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.Investigation summary: customer quality investigation: the instrument(s) was not returned, and the investigation will be completed based on the supplied image(s).The image(s) was reviewed, and the complaint condition(s) of broken was confirmed as the distal tip is broken.As the instrument(s) was not returned an as received, dimensional, material or drawing reviews are not applicable.A manufacturing record evaluation was not performed as the lot number could be determined from the image.There is no indication that a design or manufacturing issue contributed to the complaint as the circumstances during the time of the event are unknown.No new malfunctions were observed during this investigation (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history review: a manufacturing record evaluation was not performed as the lot number could be determined from the image.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) 2020, during distal fibula surgery using variable angel (va) ankle system, one (1) 2.0mm drill bit broke and one (1) screwdriver handle was damaged.The drill bit 2.0mm broke during drilling of proximal screw and the broken drill shaft was retained in drill.The broken drill tip fell onto the floor, a new drill bit was selected and the procedure continued without incident.The screwdriver handle's rotating cap broke off during use.The surgeon continued use of screwdriver without incident.There were two (2) minutes of surgical delay.Fragments were easily removed.The procedure was successfully completed.Patient outcome as planned.Concomitant device reported: unk - drill (part# unknown; lot# unknown; quantity: 1).This report is for one (1) 2.0mm drill bit/qc/125mm.This is report 1 of 2 for (b)(4).

• 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 PA 19380
• MDR Report Key: 11224429
• Report Number: 2939274-2021-00434
• Device Sequence Number: 4238894
• Product Code: HWE
• UDI-Device Identifier: 10886982186188
• UDI-Public: 10886982186188
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/30/2020

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 Model Number: 310.21
• Device Catalogue Number: 310.21
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 01/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 17 YR