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	05/18/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the placing of the graft to the patient with the biorci screw 7x25 in the femoral tunnel, a click was heard when the screw was in contact with the bone, when trying to remove the screw, there was evidence that it was fractured, leaving into the patient some fragments difficult to remove.The screw and the fragments were removed and it was replaced by another biorci device with no significant surgical delay or patient injuries.
Additional Manufacturer Narrative
Due to no product return the complaint could not be ultimately confirmed.Definitive conclusions, accurate investigation and evaluation are not possible without product to evaluate.

• 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 MA 02048
• MDR Report Key: 7549050
• Report Number: 1219602-2018-00666
• Device Sequence Number: 1187217
• Product Code: HWC
• UDI-Device Identifier: 03596010426185
• UDI-Public: (01)03596010426185(17)220822(10)50681085
• 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: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2018

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: 08/22/2022
• Device Model Number: 7207554
• Device Catalogue Number: 7207554
• Device Lot Number: 50681085
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 05/21/2018
• Initial Report FDA Received Date: 05/29/2018
• Supplement Report FDA Received Date: 07/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1