MAUDE Adverse Event Report: SYNTHES GMBH TFNA HELICAL BLADE L100 TAN; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.038.300S

Device Problem Use of Device Problem (1670)

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

Event Date 12/07/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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) 2020, the patient underwent the open reduction internal fixation surgery for the femoral trochanteric fracture with the trochanteric fixation nail advanced (tfna) helical blade.During the surgery, after the guide wire insertion, the measured value was 107mm.The surgeon thought that the value might be too long and measured again, but the measured value was 107mm and he chose the 100mm tfna helical blade.The surgeon started to insert the blade while confirming by the image intensifier.When the tip of the blade arrived the proper position, the rest of the blade was 7mm.If the blade was inserted completely, the blade would penetrate the bone head, so he removed the blade.He measured again and the measured value was 98mm.He confirmed by the image intensifier that the compression had been applied to the fractured part.The surgeon inserted the 95mm blade and the surgery was completed successfully within thirty (30) minutes delay.The surgeon commented that the disadvantage of the tfna blade is that it is difficult to deal with the fracture when the fractured fragments were moved.No further information is available.Concomitant device reported.Unknown guide wire (product# unknown, lot# unknown, qty 1), unknown insertion instrument (product# unknown, lot# unknown, qty 1).This report is for one (1) tfna helical blade 100mm sterile.This is report 1 of 1 for (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.Investigation summary: the product was returned to zuchwil customer quality for evaluation.Customer quality then conducted visual inspection and dimensional check of the returned device.During the visual inspection multiple mechanical damages were found on the surface.The anodized layer is worn away at the damages which indicates that they were caused post-manufacturing.No other visual damage could be observed at the blade.All features related to the reported complaint condition were reviewed and no other issues were identified.The returned device was tested for dimensional inspection with the result that the for the complaint relevant dimensions were found to be within specifications.According to the actual surgery technique guide, the measurement should be processed according step 6 as follows: to measure the helical blade or screw length, pass the measuring device over the guide wire to the back of the guide sleeve.The length is read directly from the measuring device.No calculations are required.Note: the measurement is calibrated from the tip of the guide wire to the tip of the tooth on the guide sleeve.As part of our quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance device history lot: manufacturing location: elmira / packaged, sterilized and released by: monument.Manufacturing date: 15-jan-2020.Expiration date: 01-dec-2029.Part number: 04.038.300s, tfna fenestrated helical blade 100mm -sterile.Lot number: 35p2765 (sterile).Note: helical blade was manufactured by elmira; lot number 32p6158.Parts were packaged, sterilized and released by monument.Production order traveler met all inspection acceptance criteria.Packaging label log (pll) lppf lmd rev ac was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 17078 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 history review 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 HELICAL BLADE L100 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11143135
• MDR Text Key: 226104827
• Report Number: 8030965-2021-00206
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.300S
• Device Lot Number: 32P6518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Date Manufacturer Received: 02/12/2021
• Patient Sequence Number: 1
• Treatment: UNK - GUIDE/COMPRESSION/K-WIRES; UNK - INSERTION INSTRUMENTS: TRAUMA