MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI-HA 7X25 8MM HEAD STERILE; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	7207675
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported screw cracked while being advanced into femoral tunnel.Screw recovered and set aside.A backup device was available to complete the procedure with no significant delay or patient injuries.
Additional Manufacturer Narrative
Device has not been returned for examination.Clinical details were provided that the patient had hard bone and that a tap was not utilized to prepare the insertion site.The starter must be utilized with the biorci-ha screws to minimize screw breakage during insertion.If hard bone is encountered, the biorci tap should be used.

• Brand Name: SCR BIORCI-HA 7X25 8MM HEAD STERILE
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7817099
• Report Number: 1219602-2018-01138
• Device Sequence Number: 2434257
• Product Code: MAI
• UDI-Device Identifier: 03596010459930
• UDI-Public: (01)03596010459930(17)201022(10)50570988
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K002274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2018

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: 10/22/2020
• Device Model Number: 7207675
• Device Catalogue Number: 7207675
• Device Lot Number: 50570988
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/14/2018
• Supplement Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 16 YR