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

Model Number	7207554
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that while the screw was being placed it broke.Damaged screw was removed and a back-up was used to complete the procedure.No significant delay or patient injury reported.
Additional Manufacturer Narrative
Due to no product return the complaint could not be ultimately confirmed.Definitive conclusions, accurate investigation and evaluation are not possible without product to evaluate.No further actions pursued at this time.If objective evidence, relevant information, package or product becomes available to assist with evaluation, the complaint will certainly be revisited.
Additional Manufacturer Narrative
One 7207554 sterile biorci pla 7x25mm screw returned.The complaint stated: "it was reported that while the screw was being placed it broke." dimensional inspection confirmed that this was a 7x25mm implant.There is approximately 1.67mm of tip material missing that was not returned.The threads and distal tip have been chewed up and tear is beginning up one side of the threads.The star hex is beginning to strip at the screw head and there are wire scuff marks inside the screw.The symptoms are consistent with entanglement with a guidewire, difficult insertion and torque placed upon the implant.The starter must be utilized with the biorci screws to minimize screw breakage during insertion and excessive force should not be placed on the delivery instrument.No root cause related to the manufacturing of this device was confirmed.

• 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: 7758612
• Report Number: 1219602-2018-00985
• Device Sequence Number: 19327945
• Product Code: HWC
• UDI-Device Identifier: 03596010426185
• UDI-Public: (01)03596010426185(17)210721(10)50612309
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K992396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/17/2018

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: 07/21/2021
• Device Model Number: 7207554
• Device Catalogue Number: 7207554
• Device Lot Number: 50612309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 09/13/2018; 10/16/2018
• Initial Report FDA Received Date: 08/07/2018
• Supplement Report FDA Received Date: 09/14/2018; 10/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1