MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI 9X25MM STRL BX 1; SCREW, FIXATION, BONE

Model Number	7207563
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/14/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the screw broke.No patient injury reported.
Additional Manufacturer Narrative
Device has not been returned for evaluation.The clinical details provided were reviewed, and it was reported that an 8mm tunnel was being utilized with this screw (9mm).

• Brand Name: SCR BIORCI 9X25MM STRL BX 1
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7643933
• Report Number: 1219602-2018-00834
• Device Sequence Number: 13484170
• Product Code: HWC
• UDI-Device Identifier: 03596010426253
• UDI-Public: (01)03596010426253(17)200720(10)50558226
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2018

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: 07/20/2020
• Device Model Number: 7207563
• Device Catalogue Number: 7207563
• Device Lot Number: 50558226
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/25/2018
• Supplement Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 06/27/2018
• Supplement Report FDA Received Date: 08/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1