MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED HELICAL BLADE 90MM - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.038.390S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation could not be completed; no conclusion could be drawn, as no product was received.(b)(4).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 reported that on (b)(6) 2020, the surgeon statically locked the trochanteric fixation nail advanced (tfna) fenestrated helical blade 90mm sterile.Post-operative follow-up films show that the helical blade had collapsed and cut out of the femoral head.It is unknown if the procedure was completed successfully.It is unknown if there was a surgical delay.Patient outcome was unknown.Concomitant device reported: 11mm/130 deg titanium trochanteric fixation nail advanced (tfna) 380mm/left - sterile (part# 04.037.159s, lot# 37p3008, quantity 1).This report is for one (1) tfna fenestrated helical blade 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.Product code 04.037.159s, lot# 37p3008 has been converted to an impacted product due to the locking mechanism failing.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 reported that on (b)(6) 2020, the surgeon statically locked the trochanteric fixation nail advanced (tfna) fenestrated helical blade 90mm sterile.Post-operative follow-up films show that the helical blade has collapsed and has cut out of the femoral head.The nails locking mechanism did not prevent the helical blade from collapsing despite the surgeon statically locking the helical blade.There is no surgical delay and no adverse event happened post-surgery.Procedure was successfully completed.The patient status after the procedure, patient has a failed device since the helical blade cut out of the head and collapsed through the nail.This is report 1 of 2 for (b)(4).
Event or Problem Description
Updated: concomitant device reported: unknown locking screws (part# unknown, lot# unknown , quantity# unknown).
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.H11 corrected data: b5, d11.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.H3, h4, h6 investigation summary: 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 history: part number: 04.038.390s, tfna fenestrated helical blade 90mm -sterile.Lot number: 25p6490 (sterile).Manufacturing location: elmira / packaged, sterilized and released by: monument.Manufacturing date: 19-nov-2019.Expiration date: 30-sep-2029.Lot quantity: 47.Note: helical blade was manufactured by elmira; lot number 20p4145.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 16830 supplied by (b)(4) 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.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.

• Brand Name: TFNA FENESTRATED HELICAL BLADE 90MM - STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10133352
• Report Number: 2939274-2020-02717
• Device Sequence Number: 14180844
• Product Code: HSB
• UDI-Device Identifier: 10886982099259
• UDI-Public: (01)10886982099259
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/28/2020

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: 04.038.390S
• Device Catalogue Number: 04.038.390S
• Device Lot Number: 23P6490
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/28/2020
• Supplement Date Received by Manufacturer: 06/18/2020; 06/23/2020; 07/09/2020
• Initial Report FDA Received Date: 06/09/2020
• Supplement Report FDA Received Date: 06/22/2020; 07/09/2020; 07/10/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 11MM/130 DEG TI CANN TFNA 380MM/LEFT - STERILE.; UNK - SCREWS: LOCKING.; 11MM/130 DEG TI CANN TFNA 380MM/LEFT - STERILE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 52