MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI 7X25MM (8MM HEAD) STRL BX 1; SCREW, FIXATION, BONE

Model Number	7207557
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/19/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that at the moment of fixing the graft (hamstring) to the patient, a 7 x 25 mm biorci screw with an 8 mm head was used, this began to fit perfectly into the tunnel, but the device lost strength during the process of screwing.It was decided to get back the screw of the tunnel, and it was broken in half, the distal part was inside the patient and it was only possible to extract the proximal part (screw head).For this reason, it was not possible to make any other type of fixation since the tip of the screw was inside the tunnel.
Additional Manufacturer Narrative
One 7x25mm biorci screw w/8mm head was returned for evaluation.Visual assessment of the screw confirmed the reported breakage.Approximately 12mm of the distal threads have broken off.Dimensional assessment of the screws major diameter and wall thickness was performed and found to meet print specification.The condition of the screw indicates it was subjected to excessive force during insertion likely due to inadequate site preparation.This investigation could not identify any evidence of product contribution to the reported complaint.

• Brand Name: SCR BIORCI 7X25MM (8MM 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: 7679746
• Report Number: 1219602-2018-00888
• Device Sequence Number: 16472835
• Product Code: HWC
• UDI-Device Identifier: 03596010426208
• UDI-Public: (01)03596010426208(17)220111(10)50641103
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2018

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: 01/11/2022
• Device Model Number: 7207557
• Device Catalogue Number: 7207557
• Device Lot Number: 50641103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2018
• Initial Date Received by Manufacturer: 06/20/2018
• Supplement Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 07/11/2018
• Supplement Report FDA Received Date: 08/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR