MAUDE Adverse Event Report: SYNTHES GMBH TROCHANTERIC FIXATION NAIL SCREW INSERTER/EXTRACTOR; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	357.428
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional device product code: hwc the device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that during a neck for femur procedure performed on an unknown date, two (2) tfn screw inserter/extractor and one (1) connecting screw short were removed from the trays because they no longer connect properly to the implants.The procedure was completed successfully by using a new tray.There was surgical delay of 5-10 minutes due to the reported event.Patient outcome is reported as fine.No further information is available.This report is for one (1) trochanteric fixation nail screw inserter/extractor.This is report 3 of 3 for complaint (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.H10 additional narrative: h3, h4, h6: part # 357.428 lot # 3l42250 manufacturing site: haegendorf release to warehouse date: march 26, 2019 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the inspection has shown that both prongs at the forefront of the instrument are strongly worn, the edges of the prongs are rounded and at the inside of the prongs are strong impression marks visible.Otherwise is the device in a good condition with no visible damages.Functional testing: in the received condition is the device not functional as required anymore as with the damaged prongs a proper connection with the counterpart wont be possible.Dimensional inspection: the relevant dimensions cannot be verified anymore due to the damages.Document/specification review: the review of the manufacturing documents has shown that the device did pass the final inspection without any issue, there was no deviation regarding dimensions or functionality.Investigation conclusion: the complaint is rated as confirmed due to the visible damages at both prongs of the device.During the performed evaluation no manufacturing related issue could be detected, the visible damages were clearly caused post-manufacturing.Based on the provided information it is not possible to determine the exact cause of the damage.The strong impression marks at the inside of the prong are an indication for a mechanical overload.It can only be assumed that the device was once not fully attached onto the neck screw during insertion or extraction while force was applied on the handle.By this the force would be applied onto the prongs instead of the hexagon as designed.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: TROCHANTERIC FIXATION NAIL SCREW INSERTER/EXTRACTOR
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11077057
• Report Number: 8030965-2020-09981
• Device Sequence Number: 14136105
• Product Code: HSB
• UDI-Device Identifier: 07611819456945
• UDI-Public: (01)07611819456945
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K092646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 357.428
• Device Lot Number: 3L42250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 12/28/2020
• Supplement Report FDA Received Date: 01/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1