MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI STERNAL LOCKING STRAIGHT PL/8 HOLES; PLATE, FIXATION, BONE

Model Number	460.045
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6), 2022, during a procedure, the pin inside the center of the plate broke inside the plate as it was undergoing bending.Three plates were affected all the same part.The procedure was completed.Another vendor¿s sternal system was used to complete the procedure.There were no fragments generated.There was no patient outcome status reported.This report involves one (1) plate.This is report 3 of 4 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: additional device product codes: (b)(4).Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j employee.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.

• Brand Name: TI STERNAL LOCKING STRAIGHT PL/8 HOLES
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13734787
• Report Number: 2939274-2022-00843
• Device Sequence Number: 5069449
• Product Code: HRS
• UDI-Device Identifier: 10887587055237
• UDI-Public: (01)10887587055237
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K093772
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 460.045
• Device Catalogue Number: 460.045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 03/11/2022
• 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: TI STERNAL LOCKING STRAIGHT PL/8 HOLES; TI STERNAL LOCKING STRAIGHT PL/8 HOLES; UNK - BENDING INSTRUMENTS; UNK - STERNAL FIXATION
• Patient Sex: Unknown