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	08/11/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer at (b)(6) a broken device during surgery.
Additional Manufacturer Narrative
This implant has been used.The screw star hex head is in reasonably good condition.Approximately 3.29mm thread tip has been separated from the rest of the screw.The distal tip portion is ripped through or cracked vertically.It has been mangled and compressed.This small distal portion has been torn from the rest of the screw.These conditions indicate force and possible encounter with another device or instrument such as the guide wire.Starter must be utilized with the biorci screws to minimize screw breakage during insertion.¿ the physical condition indicates difficulty with insertion.It was not confirmed whether ifu preparation recommendations were followed.No root cause related to the manufacturing of this device can be confirmed.

• 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: 6892092
• Report Number: 1219602-2017-01204
• Device Sequence Number: 10962689
• Product Code: HWC
• UDI-Device Identifier: 03596010426222
• UDI-Public: (01)03596010426222(17)210517(10)50601853
• Combination Product (Y/N): N
• PMA/510(K) Number: K992396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2017

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: 7207560
• Device Catalogue Number: 7207560
• Device Lot Number: 50601853
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/18/2017
• Supplement Date Received by Manufacturer: 10/24/2017
• Initial Report FDA Received Date: 09/25/2017
• Supplement Report FDA Received Date: 10/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1