MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED HELICAL BLADE 100 -S; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.038.400S
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 narrative: 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.Visual inspection: the tfna fenestrated helical blade 100 -s (p/n: 04.038.400s, lot number: h781832) was received at us cq.Visual inspection of the complaint device showed severe scratches on the surface of the device likely due to the implantation and explantation, which was not related to the complaint condition.However, the reported condition for broken could not be confirmed from the returned device.No other issues were observed with the returned device.Dimensional inspection: drawing: 04_038_370, rev.C feature: shaft outer diameter specification: 10.35 mm +0.02/-0.03 mm measured dimension: 10.35 mm result: conforming measurement device: caliper ca802 document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed ti tfna fenestrated helical blade: 04_038_370, rev.C(current and manufactured) no design issues or discrepancies were identified.Investigation conclusion: this complaint was not confirmed since the reported condition could not be confirmed.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.Device history lot - no ncr's were generated during production.Device history review - review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which 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
It was reported that on (b)(6) 2021, the patient underwent removal surgery due to a broken trochanteric fixation nail advanced (tfna).Procedure was completed successfully without any surgical delay.Concomitant device reported: unk - screw: (part# unknown; lot# unknown; quantity: unknown).Helical blades, perforated, sterile (part:04.038.400s; lot# unknown; quantity: unknown).This report is for one (1) tfna fenestrated helical blade 100 -s.This is report 2 of 3 for complaint (b)(4).

• Brand Name: TFNA FENESTRATED HELICAL BLADE 100 -S
• 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: 12393682
• Report Number: 2939274-2021-05073
• Device Sequence Number: 20014778
• Product Code: HSB
• UDI-Device Identifier: 10886982099297
• UDI-Public: (01)10886982099297
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 08/02/2021

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: 04.038.400S
• Device Catalogue Number: 04.038.400S
• Device Lot Number: H781832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 08/31/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 11/130 DEG TI CANN TFNA 380/LEFT - SILE; UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention