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

Model Number	7207554
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/26/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the biorci 7x25mm strl bx 1 screw broke while tightening.There was no patient injury reported.
Additional Manufacturer Narrative
Dimensional inspection confirms that this was a 7x25mm product.This implant has been used and is broken.Approximately 2.89mm of the implant is missing and was not returned.The threads and distal tip have been chewed up and have a lengthwise tear up one side of the threads.The appearance is consistent with tear from a guidewire or other instrument.The star hex is beginning to strip at the screw head.These visual conditions indicate contact with another device and excess force placed upon the implant.The physical condition indicates difficulty with proper insertion.No root cause related to the manufacturing of this device can be confirmed.

• Brand Name: SCR BIORCI 7X25MM (7MM HEAD) STRL BX 1
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 6937676
• Report Number: 1219602-2017-01284
• Device Sequence Number: 10961456
• Product Code: MAI
• UDI-Device Identifier: 03596010426185
• UDI-Public: (01)03596010426185(17)220309(10)50652121
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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: Other Health Care Professional
• 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: 7207554
• Device Catalogue Number: 7207554
• Device Lot Number: 50652121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2017
• Initial Date Received by Manufacturer: 10/03/2017
• Supplement Date Received by Manufacturer: 10/18/2017
• Initial Report FDA Received Date: 10/10/2017
• 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
• Patient Age: 35 YR