MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.5MM DRILL BIT/QC/GOLD/180MM; INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH

Model Number	310.23
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional procode: gff, gfa, hsz.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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, the patient underwent pelvic surgery.During the procedure, the surgeon was using a long 2.5mm drill bit to drill through the pubic crest into the ischium in order to place a long 3.5mm cortex screw through a plate into the ischium on the patients left side.The first drill bit broke after extensive use above the near cortex and the broken piece was successfully removed with a needle driver.A second 2.5mm drill bit was used to place a similar screw on the patient's other side.That drill bit also broke but the surgeon discerned that it broke off too far into the ischium to be safely removed.The surgeon continued with the surgery using a different drill bit to completion.Normal intra-operative x-rays were taken on an unknown date to determine screw placement around the broken drill bit fragment.There was a surgical delay of five (5) to seven (7) minutes.Procedure was successfully completed.Patient status is unknown.Concomitant device reported: 3.2mm percutaneous drill bit qc/300mm/calibrated (part# 324.212, lot# unknown, quantity 1) unk- screws: cortex: trauma (part# unknown; lot# unknown; quantity: unknown).This report is for one (1) 2.5mm drill bit/qc/gold/180mm.This is report 2 of 2 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10: additional narrative: h3, h4, h6: part 310.23, lot 58p5760: release to warehouse date: may 28, 2020.Supplier: (b)(4).No non-conformance reports (ncrs) were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.H3, h6: a product investigation was completed: upon visual inspection, it was observed that the distal end of the drill bit got broken.Rest of the device shows normal wear consistent with the device use which would not contribute to the complaint condition.A broken piece was returned.Functional testing of the device was not able to be performed due to the received condition of the device.But the reported embedded condition cannot be confirmed without any visual evidence like x-ray.Dimensional inspection of the received device was performed.The diameter of the device near the broken location was measured to be within the specification.The relevant drawings were reviewed; no design issues or discrepancies were noticed.The complaint condition was confirmed as the distal end of the drill bit got broken; but the reported embedded condition cannot be confirmed.While a definitive root cause cannot be determined, it is possible that the device might have encountered unintended forces.There were no issues during the manufacture of this product that would contribute to this complaint condition.During the investigation, no product design issues, or discrepancies were observed that may have contributed to the complaint condition.Based upon these results, no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.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: 2.5MM DRILL BIT/QC/GOLD/180MM
• 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: 10953617
• Report Number: 2939274-2020-05470
• Device Sequence Number: 3217065
• Product Code: HWE
• UDI-Device Identifier: 10886982186263
• UDI-Public: (01)10886982186263
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 310.23
• Device Catalogue Number: 310.23
• Device Lot Number: 58P5760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 12/18/2020
• Initial Report FDA Received Date: 12/05/2020
• Supplement Report FDA Received Date: 12/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.5MM DRILL BIT/QC/GOLD/180MM; 3.2MM PERCUTANEOUS DRILL BIT QC/300MM/CALIBRATED; UNK - SCREWS: CORTEX