MAUDE Adverse Event Report: SYNTHES GMBH MATRIXRIB INTRAMEDULLARY SPLINT MED W/4; PLATE, FIXATION, BONE

Model Number	04.501.011
Medical Device Problem Codes	Device-Device Incompatibility (2919); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Occupation: 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.Device history lot : part number : 04.501.011s; lot number: 94p7876; manufacturing site: mezzovico; release to warehouse date: 22 mar 2021; expiration date: 01 mar 2031; a manufacturing record evaluation was performed for the sterile finished lot number, and no non-conformances were identified.
Event or Problem Description
Device report from synthes reports an event in japan as follows: it was reported that this was an orif surgery for rib fracture performed on an unknown date.During surgery, after fixation with the products in question, cut-out was found.The surgeon tried to extract the screw, but the screw did not come out.Therefore, the screw was forcefully extracted from the body, and the splint and screw came out stuck together, and it became impossible to use them at other sites.After that, another plate was used to fix the fracture site.The surgery was completed successfully within 30 minutes delay.No further information is available.This complaint involves two (2) devices.This report is for one (1) matrixrib intramedullary splint med w/4.This is report 1 of 2 for complaint (b)(4).

• Brand Name: MATRIXRIB INTRAMEDULLARY SPLINT MED W/4
• Common Device Name: PLATE, 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: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16159639
• Report Number: 8030965-2023-00515
• Device Sequence Number: 20709854
• Product Code: HRS
• UDI-Device Identifier: 10887587017112
• UDI-Public: (01)10887587017112
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161590
• 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
• Report Date (Section B): 01/13/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.501.011
• Device Catalogue Number: 04.501.011S
• Device Lot Number: 94P7876
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LOCK SCREW ø2.9 SELF-TAP L8 TAN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown