MAUDE Adverse Event Report: SYNTHES GMBH TFNA FENESTRATED SCREW 100MM - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	04.038.200S
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on (b)(6) 2023, that the surgeon was fixing a hip fracture with a tfna nail and a 100 mm tfna fenestrated lag screw.During the procedure we could not get the coupling screw to thread in to the back of the lag screw so they opened another instrument set and they tried a different connecting screw which also did not work.They then opened a second 100 mm lag screw and it worked perfectly so the first one has defective threads.The surgery was successfully completed.Patient status/ outcome: successful.Concomitant device reported: unk - nails: tfna ( part # unknown, lot # unknown, quantity 1).This report is for one (1) tfna fenestrated screw 100mm - sterile.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d2b: additional product code: ktt.D9: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.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.
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: expiration date added.D9: device returned.H4: manufacture date added.H3, h4, h6: 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 the tfna fenestrated screw 100mm - sterile had the inner threads from the proximal end slightly stripped.While no root cause can be established for the observed condition, it is possible that the mating 03.037.026 - connecting screw for tfna helical blade and screw was inserted off-axis.Proper handling of the device is recommended to avoid damage in-situ.A dimensional inspection was unable to be performed due to post manufacturing damage.A functional test was unable to be performed as its mating device was not returned.However, the stripped condition of the proximal threads could have contributed to the functional issues reported.The complaint condition was not able to be replicated.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the tfna fenestrated screw 100mm - sterile would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.Device history review (dhr): manufacturing location: elmira / packaged, sterilized and released by: monument manufacturing date: 19-apr-2023 expiration date: 31-mar-2033 part number: 04.038.200s, tfna fenestrated screw 100mm -sterile lot number: 5620p34 (sterile) lot quantity: (b)(4).Note: fenestrated screw was manufactured by elmira; lot number 5070p85.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.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.D10: additional concomitant device added.Date of concomitant therapy is (b)(6) 2023.

• Brand Name: TFNA FENESTRATED SCREW 100MM - 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: 17730335
• Report Number: 8030965-2023-11440
• Device Sequence Number: 20374466
• Product Code: HSB
• UDI-Device Identifier: 10886982098771
• UDI-Public: (01)10886982098771
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 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: 04.038.200S
• Device Lot Number: 5620P34
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2023
• Supplement Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 10/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2023
• 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: CONNECSCR F/TFNA HELICAL BLADE+SCR; UNK - NAILS: TFNA; UNK - SCREWS: TRAUMA
• Patient Sex: Unknown