MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI 8X25MM STRL BX 1; SCREW, FIXATION, BONE

Model Number	7207560
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/26/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device broke during surgery.
Additional Manufacturer Narrative
One 8x25mm biorci screw was returned for evaluation.Visual assessment of the screw confirmed the reported complaint of breakage.Approximately 5mm of the distal threads have broken off and were not returned for examination.The major diameter and wall thickness of the screw was measured and found to meet print specifications.With the limited clinical details regarding patient bone quality and site preparation a root cause cannot be determined.This investigation could not identify any evidence of product contribution to the reported complaint.

• Brand Name: SCR BIORCI 8X25MM STRL BX 1
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7528507
• Report Number: 1219602-2018-00616
• Device Sequence Number: 176101
• Product Code: HWC
• UDI-Device Identifier: 03596010426222
• UDI-Public: (01)03596010426222(17)220309(10)50652123
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K992396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2018

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: 03/09/2022
• Device Model Number: 7207560
• Device Catalogue Number: 7207560
• Device Lot Number: 50652123
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/27/2018
• Supplement Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 05/19/2018
• Supplement Report FDA Received Date: 05/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1