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
Foreign zip code: (b)(6).
Event or Problem Description
It was reported that surgeon requested and opened 7x25 with 8mm head biorci-ha screw for femur, as per rci technique.He did not used a tap and used an appropriate biorci screwdriver, when the screw was being advanced into femur surgeon noted difficulty and screw broke into pieces.Screw remnants were recovered and a backup device was available to complete the procedure with no significant delay or patient injuries.
Additional Manufacturer Narrative
Examination was not possible, as the device has not been returned.Clinical details were provided that the patient had hard bone and that a tap was not utilized to prepare the insertion site.If hard bone is encountered, the biorci tap should be used.
Additional Manufacturer Narrative
One 7x25mm biorci ha screw w/8mm head was returned for evaluation.Visual assessment of the screw confirmed the reported complaint of breakage.Approximately 8mm of the distal threads have been broken off and were not returned for examination.Clinical details were provided stating that the patient had hard bone and that a tap was not utilized to prepare the insertion site.

• 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: 7817156
• Report Number: 1219602-2018-01137
• Device Sequence Number: 13739041
• Product Code: MAI
• UDI-Device Identifier: 03596010459930
• UDI-Public: (01)03596010459930(17)200629(10)50555608
• 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,Followup
• Report Date (Section B): 11/20/2018

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: 06/29/2020
• Device Model Number: 7207675
• Device Catalogue Number: 7207675
• Device Lot Number: 50555608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2018
• Initial Date Received by Manufacturer: 08/14/2018
• Supplement Date Received by Manufacturer: 09/25/2018; 11/16/2018
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 10/01/2018; 11/20/2018
• 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