MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI-HA 11X30 STERILE; SCREW, FIXATION, BONE

Model Number	7209014
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/12/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgical procedure the screw broke at the time of fixation.All parts were removed from the patient and there was no risk to the patient.
Additional Manufacturer Narrative
Due to no product return, the complaint could not be confirmed.Definitive conclusions cannot be made without a device to evaluate.Accurate investigation and evaluation are not possible.The product met specifications upon release to distribution.No further actions pursued at this time.If relevant information becomes available to assist with evaluation, the complaint will certainly be revisited.Update.
Additional Manufacturer Narrative
One 7209014 sterile 11 x 30 mm biorci-ha screw returned.The complaint indicated: ¿as reported: during the surgical procedure the screw broke at the time of fixation.¿ dimensional inspection confirms that this is an 11x 30 mm product.There is 4mm absent from the distal tip.There are scratches consistent with guide wire damage.The hex head shows signs of beginning to strip.Physical conditions are consistent with difficult insertion with excess torque.Threads have been compressed and rolled over from resistance.This is a symptom of pressure/force while seating the screw.Prep specific to this product is essential for success.Maximum surface to surface intent is achieved with interference style screws by use of same size tunnel allowing the screw threads to make optimum surface to surface contact.A smaller tunnel causes torque damages.No root cause related to the manufacturing of this device was confirmed.

• Brand Name: SCR BIORCI-HA 11X30 STERILE
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7119283
• Report Number: 1219602-2017-01546
• Device Sequence Number: 11059292
• Product Code: HWC
• UDI-Device Identifier: 03596010460189
• UDI-Public: (01)03596010460189(17)220309(10)50652158
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K002274
• 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,Followup
• Report Date (Section B): 05/03/2018

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: 03/09/2022
• Device Model Number: 7209014
• Device Catalogue Number: 7209014
• Device Lot Number: 50652158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Initial Date Received by Manufacturer: 12/13/2017
• Supplement Date Received by Manufacturer: 01/22/2018; 04/30/2018
• Initial Report FDA Received Date: 12/14/2017
• Supplement Report FDA Received Date: 01/28/2018; 05/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 37 YR