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

Catalog Number	7207554
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the device was broken.All pieces were removed with tweezers.The process was completed by enlarging one size of the hole and screw size with a backup device.No significant delay or patient injuries were reported.
Additional Manufacturer Narrative
One 7207554 sterile biorci pla 7x25mm screw used for treatment, was returned for evaluation.Dimensional inspection confirmed that this was a 7x25mm product.The physical condition indicates difficulty with proper insertion.The implant was returned fractured.Threads are of the implant were distorted with some not returned.The distal tip has been chewed up and has a lengthwise tear up one side of the threads.There is section, approximately 6.5mm, missing from one side of the screw.The appearance is consistent with tear from a guidewire or other instrument.The star hex was intact.The visual condition indicates contact with another device and excess force placed upon the implant.Interference screws achieve optimum surface to surface tension with 1:1 screw to tunnel size ratio.Complaint search revealed no other complaints for the history of this production lot.No root cause related to the manufacture of the device was confirmed.Product met specifications upon release to distribution.

• 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: 8719340
• Report Number: 1219602-2019-00731
• Device Sequence Number: 2268187
• Product Code: HWC
• UDI-Device Identifier: 03596010426185
• UDI-Public: 03596010426185
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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): 07/23/2019

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: 08/03/2023
• Device Catalogue Number: 7207554
• Device Lot Number: 50751031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Initial Date Received by Manufacturer: 06/10/2019
• Supplement Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 06/20/2019
• Supplement Report FDA Received Date: 07/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1