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

Catalog Number	7207674
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that, during the surgery, the screw broke.A backup device was available to complete the procedure with no delay or patient injuries reported.
Additional Manufacturer Narrative
Correction : lot number: (b)(4).
Additional Manufacturer Narrative
One 7x25mm biorci ha screw was returned for evaluation.Visual assessment of the screw confirmed the complaint of breakage.Approximately.5mm of the distal threads have broken off and were not returned.The break is angular in nature.Dimensional assessment of the screws major diameter and wall thickness were measured and found to meet print specifications.With the limited clinical details provided regarding site preparation, graft type, graft size and tunnel size no root cause can be determined.
Additional Manufacturer Narrative
Visual inspection and functional testing could not be performed because the device in question has not been returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.It is difficult to perform an accurate evaluation of a failure without having the failed product.As such the complaint is being closed without conclusion.

• 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: 8134392
• Report Number: 1219602-2018-01668
• Device Sequence Number: 1487455
• Product Code: HWC
• UDI-Device Identifier: 03596010426185
• UDI-Public: 03596010426185
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/12/2019

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 Catalogue Number: 7207674
• Device Lot Number: 50691799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Initial Date Received by Manufacturer: 11/15/2018
• Supplement Date Received by Manufacturer: 01/03/2019; 03/04/2019; 03/06/2019; 03/11/2019
• Initial Report FDA Received Date: 12/05/2018
• Supplement Report FDA Received Date: 01/04/2019; 03/04/2019; 03/06/2019; 03/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1