MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI 7X25MM (7MM HEAD) STRL BX 1; SCREW, FIXATION, BONE

Model Number	7207554
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/10/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the screw was passed through the guide, it came out from the tunnel, because this was broken, the doctor proceed to remove it, as the wounds were small and the screw was not very well fixed, the screw was inside the knee patient.Doctor had to make a larger incision to remove it, it was all removed and another screw was passed.A backup device was used to complete the surgery.No significant delay or patient injury reported.
Additional Manufacturer Narrative
One 7x25mm biorci screw was returned for evaluation.Visual assessment of the screw confirmed the reported complaint of breakage.Approximately 2mm of the distal threads have broken off and were not returned for examination.Dimensional assessment of the screws major diameter and wall thickness was found to meet print specification.Clinical details were provided confirming that a bone tunnel of 5.5 mm was drilled for the 7mm screw being implanted.No information was provided whether a starter or tap was utilized.Per the device ifu choose an appropriate size biorci screw.¿warning: the starter must be utilized with the biorci screws to minimize screw breakage during insertion¿.
Additional Manufacturer Narrative
H10/h11: the initial incident report was submitted with incorrect manufacturing site information and registration number (b)(4) (s+n oklahoma).The correct manufacturing site information and registration number is (b)(4) (s+n mansfield).Corrected data: d3 and g1 manufacturing site name, address and contact information.

• Brand Name: SCR BIORCI 7X25MM (7MM HEAD) STRL BX 1
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MH 02048
• MDR Report Key: 7930927
• Report Number: 1643264-2018-00760
• Device Sequence Number: 11141440
• Product Code: HWC
• UDI-Device Identifier: 03596010426185
• UDI-Public: (01)03596010426185(17)230205(10)50712632
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K992396
• 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,Followup
• Report Date (Section B): 02/08/2020

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 Expiration Date: 02/05/2023
• Device Model Number: 7207554
• Device Catalogue Number: 7207554
• Device Lot Number: 50712632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2018
• Initial Date Received by Manufacturer: 09/11/2018
• Supplement Date Received by Manufacturer: 11/16/2018; 11/16/2018
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 11/19/2018; 02/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 70