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	08/31/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ischiotibial grafts were taken and it was prepared for screw-screw technique.Graft diameter was taken, which was 8 mm, then they started to make the tunnels of the same diameter.After ascending the graft to its position, they proceeded to fix this, first in the femur; constant traction of the graft was done with the sutures in the proximal and distal part.The cannu-flex of 1.5 was placed in the femur, through which the screw 7x25 was passed, but before reaching the middle of the thread, it was broken in its distal third.Part of the screw was removed but the rest was not possible.Screw of the same diameter and length was passed without any inconvenience.There was no significant delay or patient injuries.
Additional Manufacturer Narrative
Device has not been returned for evaluation.Clinical details were provided and no starter or tap being utilized was mentioned prior to insertion of the screw.
Additional Manufacturer Narrative
One 7x25mm biorci screw was returned for evaluation.Visual assessment of the screw confirmed the reported complaint of breakage.All pieces of the screw were not returned for examination.Four small pieces were returned and due to their condition dimensional assessment is prohibitive.Clinical details were provided and there was no mention of a starter or tap being utilized prior to screw insertion.

• 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: 7858533
• Report Number: 1219602-2018-01217
• Device Sequence Number: 16603126
• Product Code: MAI
• UDI-Device Identifier: 03596010426185
• UDI-Public: (01)03596010426185(17)230301(10)50718064
• 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,Followup
• Report Date (Section B): 11/16/2018

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: 03/01/2023
• Device Model Number: 7207554
• Device Catalogue Number: 7207554
• Device Lot Number: 50718064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2018
• Initial Date Received by Manufacturer: 09/01/2018
• Supplement Date Received by Manufacturer: 10/16/2018; 11/15/2018
• Initial Report FDA Received Date: 09/08/2018
• Supplement Report FDA Received Date: 10/19/2018; 11/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1