MAUDE Adverse Event Report: SYNTHES GMBH TFNA FENESTRATED SCREW 105MM - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	04.038.205S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.
Event or Problem Description
It was reported that on an unknown date during an unknown procedure tfna step drill and screw bound on the tfna nail.It was backed out the set screw in case it had advanced down but the screw still got stuck in the nail.They then took out the screw and nail and opened new implants for each and it worked fine.Surgical delay unknown.Patient consequence unknown.This report is for one (1) tfna fenestrated screw 105mm - sterile.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.H3, h6: the device has been 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.
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, h6: manufacturing location: elmira / packaged, sterilized and released by: monument, manufacturing date: 08-may-2023, expiration date: 31-mar-2033, part number: 04.038.205s, tfna fenestrated screw 105mm -sterile, lot number: 5826p75 (sterile).Note: fenestrated screw was manufactured by elmira; lot number 5720p27.Parts were packaged, sterilized and released by monument.Production order traveler met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.This lot met all visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that there was no damage or defects with the tfna fenestrated screw 105mm - sterile.The device only has a normal signs of implantation and extraction process.The functional allegation are under the tfna body and the lock prong.A functional test was performed and both components were assembled and disassembled from the with out problems.The tfna fenestrated screw 105mm - sterile locked as intended.The tfn-advanced¿ proximal femoral nailing system (tfna) surgical technique was reviewed.Following relevant statements were found.Instrument to perform the functional test: 03.037.028 /screwdriver, hexagonal 5.0 mm, flexible.The complaint condition was not able to be replicated.Rotational locking: engaging locking mechanism against rotation the preassembled locking mechanism in the nail must be advanced to control the rotation of the blade or screw.Pass the 5 mm flexible screwdriver through the cannulated connecting screw and insertion handle until it is seated in the hexagonal recess of the locking mechanism.Turn clockwise to advance the locking mechanism.Advance the screwdriver down until it stops completely, then back the screwdriver off by turning counterclockwise 1/2 turn (180 degrees).The helical blade or screw is now locked in rotation but can still slide.Precaution: if the locking mechanism is not turned back 1/2 turn after initial tightening as described above, controlled collapse and compression of the fracture may not occur.The overall complaint was not confirmed as the tfna fenestrated screw 105mm - sterile was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that 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.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.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: TFNA FENESTRATED SCREW 105MM - STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 18534039
• Report Number: 8030965-2024-01009
• Device Sequence Number: 6676137
• Product Code: HSB
• UDI-Device Identifier: 10886982098795
• UDI-Public: (01)10886982098795
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• 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
• Report Date (Section B): 01/17/2024

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: 04.038.205S
• Device Lot Number: 5826P75
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/31/2023
• Supplement Date Received by Manufacturer: 02/13/2024; 02/27/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 02/27/2024; 02/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STEPPED REAM F/TFNA HELICAL BLADE+SCR F/; TFNA FEM NAIL Ø10 125° L170 TIMO15
• Patient Sex: Female