MAUDE Adverse Event Report: SYNTHES GMBH 3.0MM TI LOCKING SCREW 14MM F/STERNAL LOCKING PLATES; SCREW, FIXATION, BONE

Catalog Number 413.584

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2023

Event Type  malfunction  

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.Additional device product codes: hrs, jdq.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.Without a lot number the device history records review could not be completed.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.

Event Description

Device report from depuy synthes reports an event in italy as follows: it was reported that on (b)(6) 2023 during a procedure, the screws used were not compatible with the plate holes.The screw head could not be fully screwed into the plate hole.Steel wires were used in the sternum lock which further stabilized the bar to the sternum.The procedure was successfully completed without any surgical delay.There were no consequences for the patient.This report is for one (1) 3.0mm ti locking screw 14mm f/sternal locking plates this is report 6 of 9 for complaint (b)(4).

• Brand Name: 3.0MM TI LOCKING SCREW 14MM F/STERNAL LOCKING PLATES
• Type of Device: SCREW, 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 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 16420976
• MDR Text Key: 310335350
• Report Number: 8030965-2023-02190
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07611819889439
• UDI-Public: (01)07611819889439
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K093772
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 413.584
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: MATRIXMAND RECO-PL DBL-ANGL LRG T2.5 TI; STERNAL UNILOCK-SCR Ø3 SELF-TAP CRUCIFOR; STERNAL UNILOCK-SCR Ø3 SELF-TAP CRUCIFOR; STERNAL UNILOCK-SCR Ø3 SELF-TAP CRUCIFOR; STERNAL UNILOCK-SCR Ø3 SELF-TAP CRUCIFOR; STERNAL UNILOCK-SCR Ø3 SELF-TAP CRUCIFOR; STERNAL UNILOCK-SCR Ø3 SELF-TAP CRUCIFOR; STERNAL UNILOCK-SCR Ø3 SELF-TAP CRUCIFOR
• Patient Age: 19 YR
• Patient Sex: Male