MAUDE Adverse Event Report: RARON SYNTHES PRODUKTIONS GMBH 4.5/6.5 STEPPED DRILL BIT LARGE QC/485

Catalog Number	03.010.078
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on january 4, 2023, there was an issue with a couple different instruments in the frn (femoral recon nail) set.While inserting the nail, our surgeon struck the driving cap and the threaded portion broke off and became lodged in the insertion handle.Luckily, the nail was already inserted all the way so we were able to proceed with the case.In the same case, our surgeon began drilling with the stepped drill and noticed some interference between the drill and the nail.He continued to drill and then the tip of the drill broke off into the patients femoral neck.He was able to retrieve the broken piece and proceed with the case, but it certainly caused a delay.This report is for one (1) 4.5/6.5 stepped drill bit large qc/485 this is report 1 of 2 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.D9: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.E3: reporter is a j&j sales representative.H3, h4, h6: 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.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: 4.5/6.5 STEPPED DRILL BIT LARGE QC/485
• Common Device Name: DRILL BIT
• Manufacturer (Section D): RARON SYNTHES PRODUKTIONS GMBH; kanalstrasse west 30; raron 3942 ; SZ 3942
• 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: 18553601
• Report Number: 8030965-2024-01151
• Device Sequence Number: 7597583
• Product Code: HTW
• UDI-Device Identifier: 10886982067487
• UDI-Public: (01)10886982067487
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: 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: 03.010.078
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2024
• Initial Report FDA Received Date: 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: DRIVING CAP/THREADED; HAMMER GUIDE
• Patient Sex: Unknown