MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI-HA 8X20 STERILE; SCREW, FIXATION, BONE

Catalog Number	7209012
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/19/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an acl reconstruction surgery, the device broke while implanting.The broken part was removed.A backup device was available to complete the procedure with no significant delay and no patient injuries.
Additional Manufacturer Narrative
One 7209012 sterile 8 x 20 mm biorci-ha screw returned.The complaint indicated: ¿the device broke while implanting.During the surgical procedure the screw broke at the time of fixation.¿ dimensional inspection confirms that this is an 8mm product.There is approximately one to two threads absent from the distal tip.The edges are jagged and fractured.The threads remaining are rolled and compressed from resistance.The star hex is in poor condition and is beginning to strip consistent with a misfit driver or tunnel and continued attempt to rotate.Physical conditions are consistent with excess torque and difficult insertion during attempt to seat the screw.No root cause related to the manufacturing of this device was confirmed.

• Brand Name: SCR BIORCI-HA 8X20 STERILE
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8194057
• Report Number: 1219602-2018-01776
• Device Sequence Number: 11307509
• Product Code: HWC
• UDI-Device Identifier: 03596010459954
• UDI-Public: 03596010459954
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K002274
• 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): 02/15/2019

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: 09/12/2022
• Device Catalogue Number: 7209012
• Device Lot Number: 50684752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Initial Date Received by Manufacturer: 12/19/2018
• Supplement Date Received by Manufacturer: 02/14/2019
• Initial Report FDA Received Date: 12/24/2018
• Supplement Report FDA Received Date: 02/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1