MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI 8X25MM STRL BX 1; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	7207560
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that front-end of biorci screw broke during surgery.Finally, a backup device was used to complete the surgery.No patient injury was reported.
Additional Manufacturer Narrative
One 8x25mm biorci screw was returned for evaluation.Visual assessment of the screw confirmed the reported complaint of breakage.Approximately 5 mm of the distal threads have broken off and were not returned for examination.Dimensional assessment of the screws major diameter and wall thickness were found to meet print specification.As reported the screwdriver was removed from the screw during insertion then re-inserted this likely caused partial engagement leading to the distal end of the screws breakage.Per the device ifu ¿place the biorci screw securely on the screwdriver such that the screwdriver is fully engaged.Pass the screw and driver over the guide wire and into position.While applying tension to the graft, engage the screw until firmly fixed between the tunnel and the graft¿.Use error may have been a contributing factor to the event.A review of the device history record shows there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.

• Brand Name: SCR BIORCI 8X25MM STRL BX 1
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 6991934
• Report Number: 1219602-2017-01353
• Device Sequence Number: 1292945
• Product Code: MAI
• UDI-Device Identifier: 03596010426222
• UDI-Public: (01)03596010426222(17)210922(10)50622391
• Combination Product (Y/N): N
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2017

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: 09/22/2021
• Device Model Number: 7207560
• Device Catalogue Number: 7207560
• Device Lot Number: 50622391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2017
• Initial Date Received by Manufacturer: 10/30/2017
• Supplement Date Received by Manufacturer: 11/28/2017
• Initial Report FDA Received Date: 10/31/2017
• Supplement Report FDA Received Date: 11/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1