MAUDE Adverse Event Report: SYNTHES GMBH TFNA FENESTRATED HELICAL BLADE 80MM - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.038.380S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
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.If the information is unknown, not available or does not apply.H10 additional narrative: d2 additional code: e1: initial reporter is j&j company representative.H4: device history manufacturing location: elmira / packaged, sterilized and released by: monument.Manufacturing date: (b)(6) 2022.Expiration date: (b)(6) 2032.Part number: 04.038.380s, tfna fenestrated helical blade 80mm -sterile.Lot number: 2120p36 (sterile).Lot quantity: 48.Note: helical blade was manufactured by elmira; lot number 1863p39.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.Scn (b)(4), was recorded on the production order traveler.The scn supplied by sterigenics 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.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 synthes reports an event in japan as follows: it was reported that on (b)(6) 2023, the patient underwent surgery for with tfna (trochanteric fixation nail advanced) helical blades and tfna screws and nails.A migration of the blade has occurred and revision surgery occurred (b)(6) 2023.Concomitant devices: tfna nail, part# 04.037.015s, lot# 783p667.Unknown distal screw, part# unk, lot# unk.This is report 1 of 1 for (b)(4).This report is for (1) tfna fenestrated helical blade 80mm - sterile.

• Brand Name: TFNA FENESTRATED HELICAL BLADE 80MM - 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: 17050676
• Report Number: 8030965-2023-07010
• Device Sequence Number: 17008090
• Product Code: HSB
• UDI-Device Identifier: 10886982099211
• UDI-Public: (01)10886982099211
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other Health Care Professional
• Type of Report: Initial

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: 04.038.380S
• Device Catalogue Number: 04.038.380S
• Device Lot Number: 2120P36
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2022
• 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: TFNA FEM NAIL Ø10 LE 125° L235 TIMO15.; UNK - SCREWS: TRAUMA.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown