MAUDE Adverse Event Report: SYNTHES GMBH MATRIX 90° L-PLATE MED 2+2HO REVERSIBLE; PLATE, BONE

Catalog Number	04.511.305S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
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.
Event or Problem Description
It was reported that during the surgery, during the drilling process, noted the device was broken off.Another device was used to complete the surgery.There were no adverse consequences to the patient.
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 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: b5.Corrected: g1 manufacturer site.H3, h6: the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found that the matrix 90â° l-plate med 2+2ho reversible was broken at one of the holes.The broken fragment was still attached to the main body of the device.The attached fragment had a dark appearance; furthermore, at the opposite end of the same hole, drill marks could be observed.All the evidence found on the fracture surface indicates that the breakage occurred due to the drilling process.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces according to the surgical technique matrixorthognathic se_899159 rev.Ac.The following warnings are mentioned.Precautions: - confirm that plate positioning, drill bit and screw length allow for adequate clearance of nerves, tooth buds and/or tooth roots, and the edge of the bone.- drill speed rate should never exceed 1,800 rpm, particularly in dense, hard bone.- higher drill speed rates can result in: thermal necrosis of the bone, soft tissue burns, an oversized hole, which can lead to reduced pullout force, increased ease of the screws stripping in bone, suboptimal fixation, and/or the need for emergency screws.- always irrigate during drilling to avoid thermal damage to the bone.- after implant placement is complete, irrigate and apply suction for removal of debris potentially generated during implantation or removal.- avoid drilling over nerve or tooth roots.Take care while drilling as to not damage, entrap, or tear a patient¿s soft tissue or damage critical structures.- be sure to keep drill clear of loose surgical materials.Handle devices with care and dispose worn bone cutting instruments in an approved sharps container.- use the appropriate amount of screws to achieve stable fixation for fractures.Stable fixation requires a minimum of two screws per bone segment for osteotomies.Warning: instruments and screws may have sharp edges or moving joints that may pinch or tear user¿s glove or skin.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 overall complaint was confirmed as the observed condition of the matrix 90â° l-plate med 2+2ho reversible 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: sterlie part: 04.511.305s, sterile lot no:l767226, manufacturing date:05 feb,2018, expiration date:01 feb,2018, manufacturing site: werk selzach, supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Non-sterile part: 04.511.305.Non-sterile lot: l741466.Manufacturing site: werk mezzovico.Release to warehouse date: 28 jan, 2018.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.
Event or Problem Description
Additional information received: a.Was there a surgical delay in relation to the reported event? - no.B.Was other medical intervention required? - no.

• Brand Name: MATRIX 90° L-PLATE MED 2+2HO REVERSIBLE
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach CO ; SZ
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 24324851
• Report Number: 8030965-2026-01513
• Device Sequence Number: 21251322
• Product Code: JEY
• UDI-Device Identifier: 10887587023892
• UDI-Public: (01)10887587023892(17)280201(10)L767226
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K083388
• 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: 04.511.305S
• Device Lot Number: L767226
• 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: 01/30/2026
• Supplement Date Received by Manufacturer: 02/17/2026; 03/30/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 02/19/2026; 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2018
• 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