MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC UNK - PLATES: TITANIUM STERNAL FIXATION SYSTEM; PLATE,FIXATION,BONE

Device Problem Material Deformation (2976)

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

Event Date 05/07/2021

Event Type  malfunction  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent for a surgical procedure of sternum closure with sternum plates material.During the surgery, a straight plate bent with the respective bent protector screws.When these are removed, one of them remains on the plate since its cruciform edges were closed and it was not possible to extract it with the screwdriver.One screw is left implanted.There were no patient and procedure were reported.Concomitant medical products: unknown screwdriver (part # unknown, lot # unknown, quantity 1).This complaint involves three (3) devices.This report is for (1) unk - plates: titanium sternal fixation system.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).510k: this report is for an unk - plates: titanium sternal fixation system/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The 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 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: UNK - PLATES: TITANIUM STERNAL FIXATION SYSTEM
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; via cavazz 5; mezzovico ; SZ
• MDR Report Key: 11924517
• MDR Text Key: 280687415
• Report Number: 1000562954-2021-00003
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 05/07/2021

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/07/2021
• Initial Date FDA Received: 06/02/2021
• Patient Sequence Number: 1
• Treatment: TI BENDING INSERT SCR LCKNG RECON PL-5PK; UNK - PLATES; UNK - SCREWS: TRAUMA; UNKNOWN SCREWDRIVER