MAUDE Adverse Event Report: SYNTHES GMBH TFNA FENESTRATED SCREW 90MM - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	04.038.190S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/01/2023
Type of Reportable Event	Serious Injury
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.B3: event occurred on an unknown date in (b)(6) 2023.D2: additional procode: 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.
Event or Problem Description
Device report from germany reports an event as follows: it was reported that on an unknown date between (b)(6) 2023, a broken tfna screw was discovered.The product was originally implanted on (b)(6) 2023 and explanted on (b)(6) 2023.No further information is available.This report is for a tfna fenestrated screw 90mm - sterile.This is report 1 of 1 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.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Manufacturing location: elmira ¿ packaged, labeled, sterilized and released by: monument manufacturing date: 28 november 2022 expiration date: 01 november 2032 part: 04.038.190s, tfna fenestrated screw 90mm -sterile lot: 2634p04 (sterile) note: component part manufactured by elmira; lots 2404p91 and 2452p88.Production order traveler met all inspection acceptance criteria.Packaging label log (pll) was reviewed and was determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Sterilization control number (scn) supplied by jabil (abq) was reviewed and determined to be conforming.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.Photos were received for review.The x-ray investigation revealed that tfna scr perf l90 tan was broken at the distal end of the screw, near the femoral head.The overall complaint was confirmed as the observed condition of the tfna scr perf l90 tan would contribute to the complained device issue.Based on the investigation findings so far, a potential root cause cannot be stablished and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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, h4, h6: photo investigating: the product was not returned to depuy synthes, however photos were provided for review.The x-ray investigation revealed that tfna scr perf l90 tan was broken at the distal end of the screw, near the femoral head.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the tfna scr perf l90 tan would contribute to the complained device issue.Based on the investigation findings, a potential root cause cannot be stablished and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Physical device investigation: 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 distal treaded of the tfna scr perf l90 tan had broken off.And the shaft exhibits signs of deep scratches, furthermore, the anodized layer was partly abraded, this type of damage is consistent with the technique of extraction.However this complaint was confirmed as the distal end of the device had broken off.A dimensional inspection was unable to be performed due to post manufacturing damage.A functional test was not performed as it is not applicable to the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.The overall complaint was confirmed as the observed condition of the tfna scr perf l90 tan would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.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 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 90MM - 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: 18302474
• Report Number: 8030965-2023-15557
• Device Sequence Number: 19639775
• Product Code: HSB
• UDI-Device Identifier: 10886982098733
• UDI-Public: (01)10886982098733
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 04.038.190S
• Device Lot Number: 2404P91
• 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: 11/17/2023
• Supplement Date Received by Manufacturer: 12/15/2023; 02/07/2024
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 01/09/2024; 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2022
• 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: LOCKSCR F/NAILS Ø5 L32 XL25.; TFNA FEM NAIL Ø9 130° L200 TIMO15.; UNK - NAILS: TFNA.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown