MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED HELICAL BLADE 95 - SILE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	04.038.395S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code: hsb.Reporter is a j&j sales representative.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.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 or Problem Description
It was reported that, the patient underwent revision surgery for a broken titanium cannulated proximal femoral nailing system (tfna) at proximal portion.Broken nail was revised to a total hip arthroplasty.Concomitant devices reported: tfna fenestrated helical blade (part# 04.038.395s, lot# unknown, quantity 1), unknown locking screws (part# unknown, lot# unknown, quantity unknown), unknown tfna end cap (part# unknown, lot# unknown, quantity 1).This report is for one (1) tfna fenestrated helical blade 95mm.This is report 1 of 2 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.Lot manufactured in elmira as 04.038m395sp.Sterilization performed in monument as 04.038.395s.Part number: 04.038m395sp.Lot number: 42p6728.Part manufacture date: 12-feb-2020.Manufacturing location: elmira.Part expiration date: n/a.Nonconformance noted: n/a.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of tfna fenestrated helical blade 95mm - sterile product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.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.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.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.Visual inspection: the tfna fenestrated helical blade 95 - sterile(p/n: 04.038.395s & lot #: 42p6728) was returned and received at us customer quality (cq).Upon visual inspection, the surface of helical blade was nicked/scratched near the surface that goes in the tfna nail aperture which were consistent with the cosmetic damage only.Apart from it, the visual scratches were visible on the surface of blade which doesn't impact any functionality of device.No other issues were identified with the returned device.Upon visual inspection, the reported broken condition of helical blade cannot be confirmed.Device failure/defect identified? no dimensional inspection: helix od measured dimension: confirm.Diameter of blade surface that goes in tfna nail aperture measured dimension: confirm.Document/specification review.Based on the date of manufacture the following drawings, reflecting the current and manufactured revision were reviewed.Complaint confirmed? no.Investigation conclusion.The complaint condition is not confirmed for the tfna fenestrated helical blade 95 - sterile(p/n: 04.038.395s & lot #: 42p6728).During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.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 95 - SILE
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11826518
• Report Number: 2939274-2021-02376
• Device Sequence Number: 3610711
• Product Code: KTT
• UDI-Device Identifier: 10886982099273
• UDI-Public: (01)10886982099273
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2021

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: 04.038.395S
• Device Catalogue Number: 04.038.395S
• Device Lot Number: 42P6728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2021
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 06/04/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 11/125 DEG TI CANN TFNA 420/LEFT - SILE; UNK - END CAPS: TFNA; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention