MAUDE Adverse Event Report: SYNTHES GMBH 2.7 TI MATRIXRIB LCKNG SCR SELF-DRILL/9; PLATE, FIXATION, BONE

Model Number	04.501.209.01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/01/2023
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.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a j&j sales representative.Without a lot number the device history records review could not be completed.Product was not returned.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.
Event or Problem Description
It was reported that on an unknown date, during post-op dr.(b)(6) removed posterior rib plates.The patient had multiple plates behind the scapula.The patient complained of feeling the plates under the scapula.Patient was thin.There was no patient consequences.This complaint involves fourteen (14) devices.This report is for one (1) 2.7 ti matrixrib lckng scr self-drill/9.This is report 3 of 14 for complaint (b)(4).(b)(4) is related to (b)(4).(b)(4) captures 14 ips.
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.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.
Event or Problem Description
The removal surgery was performed on (b)(6) 2023.

• Brand Name: 2.7 TI MATRIXRIB LCKNG SCR SELF-DRILL/9
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16684199
• Report Number: 8030965-2023-04201
• Device Sequence Number: 8079920
• Product Code: HRS
• UDI-Device Identifier: 10887587074337
• UDI-Public: (01)10887587074337
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K190409
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• 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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.501.209.01
• Device Catalogue Number: 04.501.209.01
• 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: 03/17/2023
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 2.7 TI MATRIXRIB LCKNG SCR SELF-DRILL/9; 2.7 TI MATRIXRIB LCKNG SCR SELF-DRILL/9; 2.7 TI MATRIXRIB LCKNG SCR SELF-DRILL/9.; 2.7 TI MATRIXRIB LCKNG SCR SELF-DRILL/9.; 2.7 TI MATRIXRIB LCKNG SCR SELF-DRILL/9.; 2.7 TI MATRIXRIB LCKNG SCR SELF-DRILL/9.; 2.7 TI MATRIXRIB LCKNG SCR SELF-DRILL/9.; 2.7 TI MATRIXRIB LCKNG SCR SELF-DRILL/9.; 2.7 TI MATRIXRIB LCKNG SCR SELF-DRILL/9.; 2.7 TI MATRIXRIB LCKNG SCR SELF-DRILL/9.; 2.7 TI MATRIXRIB LCKNG SCR SELF-DRILL/9.; 2.7 TI MATRIXRIB LCKNG SCR SELF-DRILL/9.; 2.7 TI MATRIXRIB LCKNG SCR SELF-DRILL/9.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male