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	07/30/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the doctor started to screw, it was introduced no more than 5 millimeters and a strong sound was heard, it was observed by arthroscopy and the screw was broken along in two, the screw was removed from the patient knee.Another screw, same length and diameter, was passed and this worked properly.There was no significant delay or patient injuries.
Additional Manufacturer Narrative
One (b)(4) sterile biorci 7x25mm screw returned.The complaint stated: "when the doctor started to screw, it was introduced no more than 5 millimeters and a strong sound was heard, it was observed by arthroscopy and the screw was broken along in two, the screw was removed from the patient knee." dimensional inspection confirmed that this was a 7x25mm product.Approximately 1.70mm of the threaded portion is missing and was not returned.This diameter is smaller than the product diameter.There was a detailed explanation of the procedure prep.There was no mention of the required starter instrument use.The threads and distal tip were chewed up and had a lengthwise fracture up one side of the threads.The condition is consistent with tear from a guidewire or other instrument.The star hex was damaged and indicated signs of stripping at the screw head.This symptom indicates excess torque force was placed upon the implant.The physical condition indicated a difficult insertion, contact with another device and excess force placed upon the implant.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: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7776283
• Report Number: 1219602-2018-01036
• Device Sequence Number: 16583679
• Product Code: MAI
• UDI-Device Identifier: 03596010426185
• UDI-Public: (01)03596010426185(17)220822(10)50681085
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K992396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2018

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: 08/22/2022
• Device Model Number: 7207554
• Device Catalogue Number: 7207554
• Device Lot Number: 50681085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Initial Date Received by Manufacturer: 07/31/2018
• Supplement Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 08/13/2018
• Supplement Report FDA Received Date: 10/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 72