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 1 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.H3, h6: part: 357.428, lot: 8263733, manufacturing site: hägendorf, release to warehouse date: february 21, 2013.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: both prongs at the forefront of the device are deformed, one prong is bent inward and the other prong is bent outward.The edges of the prongs are strongly rounded/worn.In general is the device in a very used condition, the hexagon has strong wear marks, there are stress marks all over the shaft and the laser etching is faded due to the present wear marks.Functional testing: the device is in the received condition not functional anymore, due to the deformed prongs it will not be possible to attach the inserter onto the counterpart.Investigation conclusion: after a visual inspection per guidance provided in the document, it is determined that the reusable instrument is worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.In this relation to this complaint we also would like to mention section 2.3 regarding instruments with cams of our functional control document with end of life indicators (eoli) of reusable instruments.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.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: 11077056
• Report Number: 8030965-2020-09979
• Device Sequence Number: 14136104
• 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: 8263733
• 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