MAUDE Adverse Event Report: SYNTHES GMBH TFNA FEM NAIL Ø10 R 130° L360 TIMO15; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.037.056S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

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.Additional narrative: patient identifier: mrn: (b)(6).This report is for an unk - nails: femoral/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation due to it being implanted 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 Description

It was reported that on unknown date, the sales rep was notified that a femoral nail will be removed and a trochanteric fixation nail - advanced (tfna) would be used to replace the nail because of a non union on (b)(6) 2023.The manufacturer of the currently implanted nail was unknown.This report is for one (1) unk - nails: femoral.This is report 1 of 1 for complaint (b)(4).

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: a1: patient identifier added-mrn: (b)(6).Manufacturing location: monument; manufacturing date: 22-aug-2019; expiration date: 31-jul-2029; part number: 04.037.056s, 10mm/130 deg ti cann tfna 360mm/right ¿ sterile; lot number: 14l9200 (sterile).Production order traveler met all inspection acceptance criteria.Inspection sheet, in-process / inspect dimensional / final, ns071282 rev e met all inspection acceptance criteria apart from the four pieces noted.Inspection sheet, tfna assembly inspection, met all inspection acceptance criteria.Packaging label logs were reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn supplied was reviewed and determined to be conforming.This lot met all dimensional, visual, sterilization 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: component parts were not reviewed as the reported complaint condition of ¿replaced with this nail due to non-union¿ does not indicate breakage of the nail or any of its components.Therefore, review of the raw materials would not be pertinent to the reported complaint condition.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.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 Description

Additionally there is one distal screw that is broken.It was done because of a non union.The nail exchange was successfully completed.Additionally, the fragment of the broken 5.0mm screw remained behind.

• Brand Name: TFNA FEM NAIL Ø10 R 130° L360 TIMO15
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15366167
• MDR Text Key: 299356082
• Report Number: 8030965-2022-06461
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819650084
• UDI-Public: (01)07611819650084
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/06/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.056S
• Device Lot Number: 14L9200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/12/2022
• Initial Date FDA Received: 09/06/2022
• Supplement Dates Manufacturer Received: 02/22/2023
• Supplement Dates FDA Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 78 KG