MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 3.0MM CANNULATED SCREW 50MM; PLATE, FIXATION, BONE

Model Number	71103250S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, at the end of placing the canned screw, the head just separated from the bolt of the screw.The procedure was performed according to the surgical technique threaded guide of 1.1 was passed through a canned 2.0mm drill, and then the screws were introduced the second was the one that failed the specialist did not force the device, or performed inappropriate movements, the bolt head was removed as the body was inside the bone.The patient's health conditions are stable.No damage or danger was reported in the patient.
Additional Manufacturer Narrative
The device, used in treatment was not returned for evaluation, reporting event could not be confirmed.A clinical evaluation was conducted and confirms based on the information provided, the root cause of the reported event could not be definitively concluded.The patient impact beyond the retained fractured screw-body could not be determined and although unlikely, micro-motion and/or migration of the retained fragment (screw-body) could not be ruled out.Reportedly, the patient is stable without damage or danger and the implantable device fragment (screw-body) was retained inside the bone.No further medical assessment could be rendered at this time.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.This device is a single use, patient specific instrument; possible causes could include but not limited to new design, feature, or failure mode.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.

• Brand Name: 3.0MM CANNULATED SCREW 50MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9833777
• Report Number: 1020279-2020-00863
• Device Sequence Number: 3129889
• Product Code: HRS
• UDI-Device Identifier: 03596010624017
• UDI-Public: 03596010624017
• Combination Product (Y/N): N
• PMA/510(K) Number: K090675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2020

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: 71103250S
• Device Catalogue Number: 71103250S
• Device Lot Number: UNKNOWN/UNREADABLE
• Initial Date Received by Manufacturer: 03/01/2020
• Supplement Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 09/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1