MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR SFTSLK 2.0 PKG.8X20 STER; SCREW, FIXATION, BONE

Model Number	7207259
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/05/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during an acl revision surgery, a new 8x20mm softsilk screw was used, but the tendon was loose.The procedure was successfully completed without significant delay using a back-up 8x10mm softsilk screw into an additional bone hole.No patient injuries or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
One 7207259 soft silk 8x20mm screw used in treatment, was not returned for evaluation.Due to product unavailability, evaluation was limited.If further information, becomes available, the complaint may be revisited.Per ifu 1060403: it is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.Read these instructions completely prior to use.¿ there was compromised bone quality reported.Complaint history review indicated no similar allegations for the lot number reported.Batch review did not indicate a condition, product or procedure failure that supported the allegation.Product met specifications upon release to distribution.Root cause related to the manufacture of the device was not confirmed.Product met specifications upon release to distribution.No additional actions required at this time.
Additional Manufacturer Narrative
H11: g4: correct aware date is (b)(6) 2020.

• Brand Name: SCR SFTSLK 2.0 PKG.8X20 STER
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9848772
• Report Number: 1219602-2020-00535
• Device Sequence Number: 10944512
• Product Code: HWC
• UDI-Device Identifier: 03596010375391
• UDI-Public: 03596010375391
• Combination Product (Y/N): N
• PMA/510(K) Number: K921481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/10/2020

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: 04/01/2024
• Device Model Number: 7207259
• Device Catalogue Number: 7207259
• Device Lot Number: 50797286
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/27/2020
• Supplement Date Received by Manufacturer: 02/27/2020; 04/07/2020
• Initial Report FDA Received Date: 03/18/2020
• Supplement Report FDA Received Date: 03/18/2020; 04/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1