MAUDE Adverse Event Report: SYNTHES GMBH CONICAL EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS; EXTRACTOR

Catalog Number	03.010.000
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2024
Type of Reportable Event	Malfunction
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: 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 or Problem Description
It was reported during a surgery on (b)(6) 2024, at the time of the extraction of the nail, it was evidenced that the thread of the extraction screw was damaged and didn't fit in the nails.The nail extracted from the patient was from depuy synthes but the patient had a pseudoarthrosis, which is why it was necessary to change it to an antibiotic-releasing nail.It was necessary to extend the surgical time of the surgery about 40 minutes more than normal.The procedure was completed successfully using a universal retirement equipment that was in the institution.The patient was stable and did not present secondary or major complications.This report is for one conical extraction screw for ti femoral and tibial nails.This is report 1 of 1 for (b)(4).This report (b)(4) captures the intraoperative event, while (b)(4) captures the need for revision surgery.
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.H6: photo investigation: the device associated with this report was not returned to depuy synthes for evaluation.The photographs provided were reviewed, however the image quality in the threaded tip is poor and no observations pertaining to the nature of the reported event could be identified.Therefore, the reported condition cannot be confirmed.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was not confirmed as the photographs received are insufficient to draw a conclusion about the reported event.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.H6: device history record (dhr) review conducted: part number: 03.010.000, lot number: 91p7426, manufacturing site: hägendorf, release to warehouse date: 17-mar-2021.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.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: CONICAL EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS
• Common Device Name: EXTRACTOR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES HAEGENDORF GMBH; im bifang 6; haegendorf CO 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19614467
• Report Number: 8030965-2024-07936
• Device Sequence Number: 6306268
• Product Code: HWB
• UDI-Device Identifier: 10886982066916
• UDI-Public: (01)10886982066916
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: 03.010.000
• Device Lot Number: 91P7426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/16/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - NAILS
• Patient Sex: Female