MAUDE Adverse Event Report: SYNTHES GMBH 14MM/130 DEG TI CANN TFNA 340MM/LEFT-STERILE; ROD, FIXATION, INTRMEDULLARY AND ACCESSORIES

Catalog Number	04.037.455S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from germany reports an event as follows: it was reported that on an unknown date, a trochanteric fixation nail advanced (tfna) nail was broken.This report is for an unknown tfna nail.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.H10 additional narrative: d1, d2, d3, d4, g4 - 510k: this report is for an unknown device/unknown lot.Part and lot number are unknown; udi number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a synthes employee.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.
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.Manufacturing location: monument manufacturing date: 29-sep-2021, expiration date: 01-sep-2031, part number: 04.037.455s, 14mm/130 deg ti cann tfna 340mm/left-sterile, lot number: 411p356 (sterile), lot quantity: (b)(4).This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: part number: 04.037.912.3, tfna lock drive, lot number: 378p014, lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Inspection sheet, ns673827 rev a met all inspection acceptance criteria.Part number: 04.037.942.2, lock prong, 130 degree tfna lot number: 226p361 lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Part number: 21127, timoagri16.00 lot number: 75p4645 lot quantity: (b)(4).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 additional information is made available, the investigation will be updated as applicable.If information is obtained that was not available for this 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: 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 and review of the x-ray provided revealed that the tfna fem nail ø14 le 130° l340 timo15 was broken across the spiral blade insertion hole, both fragments were returned for evaluation.The edges of the fracture section do not indicate any signs of material issue, only smoothed out areas, most likely due to constant friction between the pieces before removal process.While no root cause can be established with the available information, factors such as the age of the patient, underlying disease, bone density, or a possible early weight-bearing, could have led to failure of the implant.A dimensional inspection for the tfna fem nail ø14 le 130° l340 timo15 was unable to be performed due to post manufacturing damage.The overall complaint was confirmed as the observed condition of the tfna fem nail ø14 le 130° l340 timo15 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.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Device history review (dhr): manufacturing location: monument, manufacturing date: 29-sep-2021, expiration date: 01-sep-2031, part number: 04.037.455s, 14mm/130 deg ti cann tfna 340mm/left-sterile, lot number: 411p356 (sterile), lot quantity: (b)(4).One piece scrapped for machine malfunction.Production order traveler met all inspection acceptance criteria aside from the one piece noted.Inspection sheet, in-process / inspect dimensional / final met all inspection acceptance criteria.Inspection sheet, tfna assembly inspection met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.Scn supplied by jabil (abq) was reviewed and determined to be conforming.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: part number: 04.037.912.3, tfna lock drive lot number: 378p014 lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Inspection sheet, ns673827 rev a met all inspection acceptance criteria.Part number: 04.037.942.2, lock prong, 130 degree tfna lot number: 226p361 lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Part number: 21127, timoagri16.00 lot number: 75p4645 lot quantity: (b)(4).Inspection instruction met all inspection acceptance criteria.Certified test report supplied by perryman company dated 02-oct-2020 was reviewed and determined to be conforming.Lot summary report dated 24-aug-2021 met all inspection acceptance criteria.Raw material receiving / putaway checklist met all inspection acceptance criteria.This lot met all dimensional, visual, 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.

• Brand Name: 14MM/130 DEG TI CANN TFNA 340MM/LEFT-STERILE
• Common Device Name: ROD, FIXATION, INTRMEDULLARY 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: 17961323
• Report Number: 8030965-2023-13128
• Device Sequence Number: 17901220
• Product Code: HSB
• UDI-Device Identifier: 10886982097590
• UDI-Public: (01)10886982097590
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 04.037.455S
• Device Lot Number: 411P356
• 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: 10/05/2023
• Supplement Date Received by Manufacturer: 11/15/2023; 01/29/2024
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 12/05/2023; 02/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2021
• 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 Ø5 L36 F/NAILS TAN LIGHT GREEN; LOCKSCR Ø5 L38 F/NAILS TAN LIGHT GREEN; TFNA HELICAL BLADE PERF L110 TAN
• Patient Sex: Unknown