MAUDE Adverse Event Report: SYNTHES GMBH CONICAL EXTRACTION SCREW FOR LARGE SCREWS & 4.9MM BOLTS; EXTRACTOR

Catalog Number	309.530
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2025
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, a removal surgery was performed.On (b)(6) 2023, a primary surgery was performed with the lcpdf.When the surgeon tried to remove the locking screw, the screw head got stripped.Although the extraction screw in question was used, the extraction screw broke.The surgery was completed successfully without any surgical delay.The sales rep is confirming about details.No further information is available.
Event or Problem Description
Additional information was received from sales rep and states that: six screws got stripped.Three of six screws were able to be removed with the extraction screw.When removing one screw of remaining three screws, the extraction screw broke.As a result, three screws and plate remained in the patient.The surgery was completed successfully within 45 minutes delay.The surgeon guessed that the breakage was caused by metal fatigue; however, he demands to investigate whether there are any defects in the manufacturing process.
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 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.H3, h6: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found the tip of was damaged broken.A piece of the broken tip was returned, but not all fragments were included in the return.Additionally, a small fragment with visible geometric crystals was returned.Infrared spectroscopy indicated that the material exhibited an infrared spectrum characteristic of biological substances.This, combined with its morphological features, suggests that the material originated from a medical procedure involving tissue.Please refer to the attachment "(b)(4) laboratory report" for infrared spectroscopy details results.The observed condition of the device was consistent with a component failure that was caused by exposure to unintended forces.Surgical technique se_853188 rev.Ac was reviewed and the following relevant statement was found at page 19: insert the tip of the conical extraction screw into the screw recess and hold it as vertical as possible.Turn anticlockwise, exerting pressure, until the extraction screw grasps into the screw recess.Continue to turn anticlockwise and remove the screw.Note: during insertion ensure that enough axial pressure is exerted and retain the axis.Only use sharp-edged extraction screws (recommendation: one extraction).Do not use extraction screws with power tools.A dimensional inspection was unable to be performed due to the post-manufacturing damage.A functional test was not performed since it was not applicable to the complaint condition.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, 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, lot number: 94p6079.It was electronically reviewed and no nonconformances/manufacturing irregularities were identified during the manufacturing process.The product was released on: 29 apr 2021, manufacturing site: jabil bettlach.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: CONICAL EXTRACTION SCREW FOR LARGE SCREWS & 4.9MM BOLTS
• Common Device Name: EXTRACTOR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach CO ; SZ
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 21702300
• Report Number: 8030965-2025-02816
• Device Sequence Number: 8636555
• Product Code: HWB
• UDI-Device Identifier: 07611819018457
• UDI-Public: (01)07611819018457(10)94P6079
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,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: 94P6079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2025
• Supplement Date Received by Manufacturer: 04/01/2025; 05/08/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 04/02/2025; 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2021
• 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
• Patient Age: 21 YR
• Patient Sex: Male