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 Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2020
Type of Reportable Event	Malfunction
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 1 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.H3, h4, h6: part 310.23, lot h685148: manufacture date: july 31, 2018.Manufacturing location: elmira.A review of the device history record revealed no complaint related anomalies.The device history record shows lot h685148 of 2.5mm drill bit was processed through the normal manufacturing and inspection operations with no non-conformances or rework noted.The lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the component device history record revealed no complaint related anomalies.Component lot was processed through the normal manufacturing and inspection operations with no non-conformances or rework noted.A review of the device history record for the raw material revealed no complaint related anomalies.The device history record shows lot met all requirements at the time of release with no issues documented during the manufacture that 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.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.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: 10951578
• Report Number: 2939274-2020-05469
• Device Sequence Number: 14257202
• 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?: No
• 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: H685148
• 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