MAUDE Adverse Event Report: SYNTHES GMBH EXTRACT-SCREW CONI F/SCR Ø4.5+6.5; EXTRACTOR

Catalog Number	309.530
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #(b)(4).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.H11 additional narrative: 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 that on (b)(6) 2025, the patient underwent the removal surgery for femoral fracture.During the lcp-df removal surgery, extract-screw was used because it was difficult to remove the locking screw.However, even the extract-screw could not remove the locking screw and it broke.Two extract screws were broken.Although the broken fragments remained in the screw head, the surgeon gave up on removal and closed the wound.The surgery was completed successfully within 30 minutes surgical delay.No further information is available.
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.H11 additional narrative: added: d9, h4 corrected: e1 (facility name), e4 h3, h6: the device was 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.
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.H11 additional narrative: h3, h6: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found that the threaded tip of the extract-screw coni f/scr ø4.5+6.5 was broken.Not all the broken fragment were not returned for evaluation.The fracture surface was examined, and no issues related to material was observed.No post operative x-rays were provide, therefore it's not possible to confirm that the fragments remains inside the patient.In addition to the broken condition, the threaded tip was also stripped.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces a dimensional inspection was unable to be performed due to the post-manufacturing damage.A functional test was unable to be performed due to the post-manufacturing damage.The unable to assemble allegation can be confirmed due to the damage observed.The overall complaint was confirmed as the observed condition of the extract-screw coni f/scr ø4.5+6.5 would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to component failure, and 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 reported complaint condition.As part of j&j medtech orthopaedics 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.Device history review: a manufacturing record evaluation was performed for the finished device.Product code: 309.530-15.Lot number: 8358p79.It was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 29 nov 2023.Manufacturing site: jabil bettlach.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: EXTRACT-SCREW CONI F/SCR Ø4.5+6.5
• Common Device Name: EXTRACTOR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 22383402
• Report Number: 8030965-2025-06729
• Device Sequence Number: 7054044
• Product Code: HWB
• UDI-Device Identifier: 10886982185846
• UDI-Public: (01)10886982185846(10)8358P79
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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: 309.530
• Device Lot Number: 8358P79
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/16/2025
• Supplement Date Received by Manufacturer: 07/09/2025; 07/21/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 07/10/2025; 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2023
• 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
• Patient Sex: Unknown