MAUDE Adverse Event Report: SYNTHES GMBH 11MM/125 DEG TI CANN TFNA 235MM/LEFT - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.037.115S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from the netherlands reports an event as follows: it was reported that on an unknown date in 2023, the patient experienced breakage of the tfna nail just under the column screw.The event occurred 3 months after the initial implantation.Surgery was performed to remove the broken tfna and to implant a new, thicker and longer tfna.No further information was provided.This report is for a 11mm/125 deg ti cann tfna 235mm/left ¿ 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.Additional narrative: event occurred on an unknown date in 2023.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device visual analysis of the photo revealed that the tfna fem nail ø11 le 125° l235 timo15 was broken across the tfna screw insertion hole.X-ray images provided show a nail and screw construct at the left proximal femur with signs of a sub trochanteric fracture of the bone.Comparison of the x-rays from 23-02-2023 and 13-03-2023 can confirm that the nail initially had no signs of issue and posteriorly it got broken.Therefore, complaint condition can be confirmed.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for the tfna fem nail ø11 le 125° l235 timo15.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 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.Investigation summary: 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 fem nail ø11 le 125° l235 timo15 was broken across the tfna screw insertion hole.Broken fragment was returned for evaluation.A dimensional inspection was not performed for the tfna fem nail ø11 le 125° l235 timo15 due to post manufactured damage.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 tfna fem nail ø11 le 125° l235 timo15 would contribute to the complained issues.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.Drawing/specifications reviewed: yes.Dimensional inspection: n/a.Device history lot: manufacturing location: monument.Manufacturing date: 10-jun-2022.Expiration date: 01-jun-2032.Part number: 04.037.115s, 11mm/125 deg ti cann tfna 235mm/left-sterile.Lot number: 861p556 (sterile).Lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Inspection sheet, in-process / inspect dimensional / final ns071289 rev g met all inspection acceptance criteria.Inspection sheet, tfna assembly inspection ns067861 rev c met all inspection acceptance criteria.Packaging label log (pll) lmd rev ad was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 22736 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: 04.037.912.2, lock prong, 125 degree tfna static locking prong.Lot number: 828p538.Lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Part number: 04.037.912.3, tfna lock drive.Lot number: 838p876.Lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Inspection sheet, ns673827 rev a met all inspection acceptance criteria.Part number: 21127, timoagri16.00.Lot number: 476p935.Lot quantity: (b)(4).Inspection instruction met all inspection acceptance criteria.Certified test report supplied by perryman company dated 02-dec-2021 was reviewed and determined to be conforming.Lot summary report dated 16-may-2022 met all inspection acceptance criteria.Raw material receiving / putaway checklist met all inspection acceptance criteria.Device history review: 19-may-2023: dhr reviewed by: mschoenfeld 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.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.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 further reported that the revision surgery occurred on (b)(6)2023.The procedure was completed successfully with no delay.

• Brand Name: 11MM/125 DEG TI CANN TFNA 235MM/LEFT - STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16674981
• Report Number: 8030965-2023-04095
• Device Sequence Number: 20192330
• Product Code: HSB
• UDI-Device Identifier: 10886982096333
• UDI-Public: (01)10886982096333
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K131548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.037.115S
• Device Catalogue Number: 04.037.115S
• Device Lot Number: 861P556
• 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: 03/16/2023
• Supplement Date Received by Manufacturer: 04/04/2023; 05/15/2023; 06/06/2023
• Initial Report FDA Received Date: 04/04/2023
• Supplement Report FDA Received Date: 04/21/2023; 05/30/2023; 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2022
• 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 Ø5 L34 F/NAILS TAN LIGHT GREEN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female