MAUDE Adverse Event Report: SYNTHES GMBH MATRIX LOCK SAGITT-SPLIT PL CURV W/INTER; PLATE, FIXATION, BONE

Catalog Number 04.511.971S

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 01/01/2022

Event Type  Injury  

Event Description

Device report from synthes reports an event in japan as follows: it was reported that an unknown surgery was performed to implant the plate on (b)(6) 2022.Several weeks after the surgery, the plate in question broke.In the initial surgery, 2 plates (04.511.971s and 04.503.711s) had been used, and among these 2, 04.511.971s broke.A removal surgery is scheduled for (b)(6) 2023.No further information is available.This report involves one matrix lock sagitt-split pl curv w/inter.This is report 1 of 1 for (b)(4).

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.Date of event: only the event year is known.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter is a j&j employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or 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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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.H3, h4, 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.Device history lot roduct code: 04.511.971s, lot number: 586p306, manufacturing site: mezzovico , release to warehouse date: 28 jan 2022, expiration date: 01 jan 2032.A manufacturing record evaluation was performed for the sterile finished lot number, and no non-conformances were identified.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.G4: device is not distributed in the united states, but is similar to device marketed in the usa.

• Brand Name: MATRIX LOCK SAGITT-SPLIT PL CURV W/INTER
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico CO 6805 ; SZ 6805
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15885973
• MDR Text Key: 304520161
• Report Number: 8030965-2022-10399
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• 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

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.511.971S
• Device Lot Number: 586P306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: MATMAND PL CRESCENT 2+2HO T1.25 TI; UNK - SCREWS: TRAUMA
• Patient Outcome(s): Required Intervention