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	09/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported during left acl reconstruction surgeon asks nurses to open a 7x25mm biorci - ha screw for femur.Screw broke into pieces while being implanted into femoral tunnel.A backup device was available to complete the procedure.Procedure delay was about 10-15 minutes and no patient injuries were reported.
Additional Manufacturer Narrative
The investigation was limited to the information provided as the device was not returned for examination.The investigation could not draw any conclusions about the reported 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.
Event or Problem Description
It was confirmed all broken pieces were removed from the patient.

• 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: 6890094
• Report Number: 1219602-2017-01200
• Device Sequence Number: 18861012
• Product Code: MAI
• UDI-Device Identifier: 03596010459930
• UDI-Public: (01)03596010459930(17)210922(10)50622408
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2017

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 Model Number: 7207675
• Device Catalogue Number: 7207675
• Device Lot Number: 50622408
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/21/2017
• Supplement Date Received by Manufacturer: 09/27/2017
• Initial Report FDA Received Date: 09/25/2017
• Supplement Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 25 YR