MAUDE Adverse Event Report: SYNTHES GMBH MATRIXSTERNUM SCRGUIDE LRG 8 HO; PLATE, FIXATION, BONE

Catalog Number	03.501.453
Medical Device Problem Codes	Entrapment of Device (1212); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the cardiac team was finishing a cabg and using the matrixsternum system to close the sternum.The surgical team had already started implanting hardware before the sales representative arrived.When the sales representative entered, one of the team stated that "the screw went right through the sternum".The team had forgotten to attach the plate to the bottom of the speed guide.Since there was no plate affixed to the speed guide, when they went to implant the screw, the screw was inserted through the sternum.Multiple hcps scrubbed in and attempted to locate the screw.Both x-ray and c-arm were utilized intra-op to locate the screw.The team was unable to locate the screw.An overnight ct confirmed the location of the screw - it was inserted into the left ventricle of the heart.The team plans to bring the patient back into the or to retrieve the screw.Surgery was delayed by 240 minutes.Multiple hcps scrubbed in to locate the screw in the chest wall.X-ray and c-arm were utilized to locate the screw and attempts were unsuccessful.The team was not able to locate it intra-op and ordered an overnight ct to get a better visual.Overnight ct confirmed location of the screw inside the heart.Fragments were generated.
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 narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
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.H11 additional narrative: added: h6 (health effect - impact code) corrected: h5 recaptured codes on h6 (medical device problem code) h3, h6: product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MATRIXSTERNUM SCRGUIDE LRG 8 HO
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 23393278
• Report Number: 8030965-2025-10729
• Device Sequence Number: 10034435
• Product Code: HRS
• UDI-Device Identifier: 10887587078267
• UDI-Public: (01)10887587078267
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K233967
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 03.501.453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/08/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Unknown