MAUDE Adverse Event Report: SYNTHES GMBH LOCKSCR ø2.7 HEAD LCP2.4 SELF-TAP L8 TAN; SCREW, FIXATION, BONE

Catalog Number	402.208TS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2026, the patient underwent an orif for distal fibula with the screwdriver.Before the surgery, the sales rep was informed in advance that the surgeon's technique would involve inserting screws of around 10mm with a power tool.During the surgery, the surgeon also informed the sales rep that inserting all screws with a power tool, attach a torque limitation attachment to the driver handle, and perform final tightening by hand.A t8 screwdriver tip was attached to the power tool and a 2.7mm f8mm long screw was inserted.When attempting final tightening by hand, the surgeon realized that the screwdriver tip had broken and become lodged in the recess.After removing the kw that temporarily fixed the plate and removing the plate, it was discovered that the screw had also broken underneath the plate, so the broken screw was extracted with a radio-pen.As the plate and screw had become one, they could not be reused, and the surgery was completed using a 5-hole posterolateral dfp.The surgery was completed successfully with no delay.No further information is available.
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 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: 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: corrected: g1.H3, h6: the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found to be broken from the head.The broken fragment was returned for evaluation.While no root cause can be established with the available information, factors such as the patient's age, underlying disease, bone density, or a possible early weight-bearing, could have led to implant failure.A dimensional inspection was not performed since it was not applicable to the complaint condition.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 lockscr ã¸2.7 head lcp2.4 self-tap l8 tan would have contributed to the complained device issue.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 reported 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.Device history lot: part number: 402.208ts.Lot number: 5434p76.Manufacturing site: mezzovico.Release to warehouse date: 03 may 2023.Expiration date: 01 apr 2028.A manufacturing record evaluation was performed for the sterile finished lot number, 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: LOCKSCR ø2.7 HEAD LCP2.4 SELF-TAP L8 TAN
• Common Device Name: SCREW, FIXATION, BONE
• 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: 24390463
• Report Number: 8030965-2026-01682
• Device Sequence Number: 10289299
• Product Code: HWC
• UDI-Device Identifier: 10886982205704
• UDI-Public: (01)10886982205704(17)280401(10)5434P76
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K113364
• 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: 402.208TS
• Device Lot Number: 5434P76
• 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: 02/02/2026
• Supplement Date Received by Manufacturer: 02/24/2026; 03/13/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 02/25/2026; 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2023
• 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: LCP POSTLAT DISTAL FIBULA PLATE 2.7/3.5; SCRDRIVER SHAFT T8 SELF-HOLDING
• Patient Sex: Unknown