MAUDE Adverse Event Report: SYNTHES GMBH HELICAL BLADE INSERTER; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	03.037.024
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on an unknown date, during a tfna case, the helical blade inserter and coupling screw would not detach from the helical blade.The surgeon and scrub tech use the flexible screwdriver and pin wrench to unthread the coupling screw, but it would not budge.He then tried to uncouple the screw and inserter from the helical blade after the case, and even he could not get it out.The case was delayed 5 minutes because staff had to open a second tfna locking tray for a second helical blade inserter and had to open a second implant.There were no patient consequences, and the procedure proceeded accordingly.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.D4: udi: as the catalog/model number and lot number for the device involved in the event was not provided, the full udi is currently not available.D1, d2, d3, d4, g4-510k: this report is for an unk - insertion instruments: t: trauma/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.H6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.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 information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: HELICAL BLADE INSERTER
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• 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: 20561529
• Report Number: 8030965-2024-13362
• Device Sequence Number: 19645939
• Product Code: HSB
• UDI-Device Identifier: 10886982070401
• UDI-Public: (01)10886982070401
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• 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,Followup,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: 03.037.024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/22/2024
• Supplement Date Received by Manufacturer: 11/06/2024; 11/18/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 11/13/2024; 11/21/2024
• 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: HELICAL BLADE/SCREW COUPLING SCREW; UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE
• Patient Sex: Unknown