MAUDE Adverse Event Report: ELMIRA SYNTHES USA LLC TFNA FENESTRATED HELICAL BLADE 95MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.038.395

Device Problems Device Slipped (1584); Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/10/2021

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is a j&j employee.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent the open reduction internal fixation surgery for trochanteric fracture with tfna helical blades in question.During the surgery, the sales rep saw a gap between the implant and the connection part of the insertion instrument on the fluoroscopic screen which would not occur if it was connected normally.He reported to the surgeon and the surgeon removed the implant.The surgeon used the other same size implant which was going to be used in other surgery.Procedure was completed successfully with thirty(30) minutes surgical delay.Concomitant device reported: unknown hammer (part# unknown; lot# unknown; quantity: 1).Unknown reamer (part# unknown; lot# unknown; quantity: 1).This report is for one (1) tfna fenestrated helical blade 95mm - sterile.This is report 1 of 2 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.The product was returned to us cq for evaluation.The us cq team conducted a visual inspection of the returned device visual analysis of the returned sample revealed that tfna fenestrated helical blade 95mm there are few scratches on the device which doesn¿t affect the functionality of the device and no other issues were identified.The dimensional inspection was not performed due to alleged condition.Functional test cannot be performed since the device was received by itself.The observed condition of tfna fenestrated helical blade 95mm in the device was not consistent with the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for tfna fenestrated helical blade 95mm.While no definitive root cause could be determined, there is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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 part number: 04.038m395sp, lot number: 24p6708, part manufacture date: 01-nov-2019, manufacturing location: elmira, 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 in elmira 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.Further processing including sterilization is performed in monument where the part number converts to 04.038.400s.No monument operations were included in this dhr review.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.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 95MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): ELMIRA SYNTHES USA LLC; 35 airport road; horseheads NY 14845
• MDR Report Key: 12441857
• MDR Text Key: 271128763
• Report Number: 8030965-2021-07571
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819652583
• UDI-Public: (01)07611819652583
• Combination Product (y/n): N
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.395
• Device Lot Number: 26P4787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2021
• Date Manufacturer Received: 09/22/2021
• Patient Sequence Number: 1
• Treatment: UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA; UNK - INSERTION INSTRUMENTS: TRAUMA; UNK - REAMERS