MAUDE Adverse Event Report: SYNTHES GMBH 1.5MM TI VAL T-PLATE 3H HEAD-7H SHAFT-STERILE; SCREW, FIXATION, BONE

Catalog Number	04.130.252S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, the patient underwent orif surgery for the index finger proximal phalanx base fracture with the plate.When the surgeon tried to cut the plate to fit the patient's size, the product broke in a place where it should not have been cut.The surgeon was well experienced and have used same product many times, and the surgeon perspective that there was no problem with the cutting technique.The surgeon believes that there was no problem with the technique but has never experienced anything like this before.The surgery was completed successfully with no delay.Patient is listed as stable.
Additional Manufacturer Narrative
J&j medtech is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which j&j medtech has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, j&j medtech or its employees that the report constitutes an admission that the device, j&j medtech, or its employees caused or contributed to the potential event described in this report.Additional narrative: 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 j&j medtech orthopaedics for evaluation.The j&j medtech orthopaedics team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the va locking t-plate 1.5 with 3 holes on the shaft and 7 holes was observed broken into four fragments.The damaged area was examined and the plate appeared to be under stress that can lead to material fatigue, weakening the component and causing fractures.Per variable angle locking hand system surgical technique guide precaution: reverse bending or use of the incorrect instrumentation for bending may weaken the plate and lead to premature plate failure (e.G.Breakage).Do not bend the plate beyond what is required to match the anatomy.When using the plate holding forceps with pointed ball tip, avoid the tendons and avoid applying excessive pressure.A dimensional inspection for the va locking t-plate 1.5 he 3ho shaft 7ho was not performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of theva locking t-plate 1.5 he 3ho shaft 7ho would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: 04.130.252s.Lot number: 35597p9.Manufacturing site: mezzovico.Release to warehouse date: 17 oct 2024.Expiration date: 01 oct 2034.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: 1.5MM TI VAL T-PLATE 3H HEAD-7H SHAFT-STERILE
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico CO ; SZ
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 22213461
• Report Number: 8030965-2025-05997
• Device Sequence Number: 18179860
• Product Code: HWC
• UDI-Device Identifier: 10886982112910
• UDI-Public: (01)10886982112910(17)341001(10)35597P9
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141527
• 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

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: 04.130.252S
• Device Lot Number: 35597P9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2024
• 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
• Patient Sex: Unknown