MAUDE Adverse Event Report: SYNTHES GMBH 2.0MM RAPID RESORBABLE CORTEX SCREW 4MM-STERILE; PLATE, BONE

Catalog Number	806.004.02S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H11 additional manufacturer narrative: d4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.
Event or Problem Description
It was reported that during the surgery, when insert the screw, the screw was broken, all the pieces were removed from the patient.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.
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, d10 the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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: added: h4.Corrected: g1.H3, h6: the product was returned to depuy synthes for evaluation.Visual inspection of the returned device revealed only the screw head was returned for analysis.The broken threaded body fragment was not returned for examination.The observed condition is consistent with a torsional failure which is likely due to the application of significant torque during the implantation process.According to the surgical technique rapidsorb resorbable fixation system se_808132, rev.Aa the following are mentioned: important: if the tap selected is too short, it will not be possible to countersink the screw completely in the plate hole and further screwing in will inevitably lead to breakage of the screw.This can also occur if tapping is terminated before the tap shoulder has reached the plate surface.Carefully insert the selected screw, using the appropriate screwdriver, until the screw is countersunk in the plate.Use a light, two-finger approach (thumb and index finger) to insert the screw.To prevent breakage, do not overtighten the screws.Stop immediately when the screw has made full contact with the plate.Over insertion of the screw beyond its initial contact with the plate may result in breakage or deformation of the screw head.A dimensional inspection could not be performed due to the 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 1.5mm rapid resorbable cortex screw 6mm- was consistent with the reported condition.Based on the investigation findings, the potential cause is traced to the application of significant torque during implantation.There is no indication that a design or manufacturing issue has caused the reported complaint's condition, and it has been determined that no corrective and/or preventive action is proposed.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.Device history lot: part: 806.004.02s, lot: 356l144, manufacturing site: werk bio oberdorf, supplier: na, release to warehouse date:18 dec 2024, expiration date; na.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2.0MM RAPID RESORBABLE CORTEX SCREW 4MM-STERILE
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf CO ; SZ
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 24303054
• Report Number: 8030965-2026-01425
• Device Sequence Number: 14781027
• Product Code: JEY
• UDI-Device Identifier: 20887587061815
• UDI-Public: (01)20887587061815
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K062789
• 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: 806.004.02S
• Device Lot Number: 356L144
• 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: 01/27/2026
• Supplement Date Received by Manufacturer: 02/19/2026; 03/03/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 03/03/2026; 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1.5MM RAPID RESORBABLE CORTEX SCREW 6MM.
• Patient Sex: Unknown