MAUDE Adverse Event Report: SYNTHES GMBH 4.2MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATION

Catalog Number	03.010.061
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2024, the patient underwent an orif surgery for a femoral trochanteric fracture.The surgeon inserted the nail in question by hammering but gave up halfway through its insertion.The surgeon removed the nail and done reaming until 11 mm.The drill bit for locking screws interfered with the nail, but the surgeon continued the surgery.After insertion of the end cap, the locking screw was found to be inserted out of the hole toward the anterior femur.The surgeon removed the locking screw and end cap, reattached the insertion handle, drilled at the dynamic hole, and succeeded in inserting the locking screw without interference.The assistant surgeon presumed that the hammering during nail insertion loosened the screws on the aiming arm, which may have caused the locking screw to be inserted out of the hole.The surgery was completed successfully within 30 minutes delay.This report involves one (1) 4.2mm three-fluted drill bit qc/330mm/100mm calibration.This is report 3 of 4 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.D9: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.E3: reporter is a j&j employee.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.

• Brand Name: 4.2MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATION
• Common Device Name: DRILL BIT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19765888
• Report Number: 8030965-2024-08846
• Device Sequence Number: 8578926
• Product Code: HTW
• UDI-Device Identifier: 07611819760899
• UDI-Public: (01)07611819760899
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 03.010.061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 125 DEG AIMING ARM STATIC+DYNAMIC; LOCKSCR Ø5 L32 F/NAILS TAN LIGHT GREEN; TFNA FEM NAIL Ø10 R 125° L235 TIMO15; UNK - END CAPS; UNK - NAIL INSERTION HANDLES
• Patient Sex: Unknown