MAUDE Adverse Event Report: SYNTHES GMBH DRILL BIT FOR 5.0 RECON SCREWS/LARGE QC; BIT, DRILL

Catalog Number	03.010.228
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/30/2023
Type of Reportable Event	Malfunction
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: d9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.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 an unknown date, the surgeon was repairing a midshaft femur of patient.Adolescent nail was chosen for the repair.The standard entry point was chosen and the canal was opened with the appropriate entry reamer.2.5mm ball tip guide wire was inserted and flexible reamers were used to a 12mm diameter.Surgeon measured for length and a 10x400 mm left adolescent nail was inserted to the proper depth.Guide wires were inserted to the proper depth in both recon screw guide sleeves.Guide wires were measured for length.90 mm recon screws were requested.Surgeon removed first guide wire in the inferior recon sleeve and drilled with recon drill bit.90mm recon screw was inserted to the correct depth.Second guide wire was removed and drill bit 03.010.228 was utilized again.The tip of the drill bit broke off in the neck of the femur.Surgeon chose to place the 90mm recon screw 04.031.028, but the fragment pushed the screw to superior.A 50mm recon screw was chosen and the 90mm recon screw was removed.Surgeon decided to place a 4mm transverse screw as well to bolster fixation due to short recon screw used.15 minutes were added to the case to replace 90mm recon screw to the smaller 50mm recon screw and the additional 4mm transverse screw placement.Case was finished successfully, with 15 minutes delay but a fragment was left in the patients femoral neck.Concomitant device reported: unk - nails (part# unknown; lot# unknown; quantity: unknown) unk - reamers (part# unknown; lot# unknown; quantity: unknown) unk - guide/compression/k-wires (part# unknown; lot# unknown; quantity: unknown) unk - guides/sleeves/aiming: guide (part# unknown; lot# unknown; quantity: unknown) this report is for one (1) drill bit for 5.0 recon screws/large qc this is report 1 of 1 for complaint (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.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Part: 03.010.228, synthes lot: u319792, supplier lot: u319792, release to warehouse date: oct 08,2018, supplier: (b)(4), no ncrs were generated during production.Product was not returned.Based on the information available, it has been determined that no corrective and 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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DRILL BIT FOR 5.0 RECON SCREWS/LARGE QC
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17755297
• Report Number: 8030965-2023-11637
• Device Sequence Number: 6664513
• Product Code: HTW
• UDI-Device Identifier: 10886982068101
• UDI-Public: (01)10886982068101
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

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: 03.010.228
• Device Lot Number: U319792
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2023
• Supplement Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 10/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2018
• 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: 5.0 TI RECON SCREW W/T25 SDDRIVE 90; UNK - GUIDE/COMPRESSION/K-WIRES; UNK - GUIDES/SLEEVES/AIMING: GUIDE; UNK - NAILS; UNK - REAMERS
• Patient Age: 13 YR
• Patient Sex: Male
• Patient Weight: 79 KG