MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI 8X30MM STRL BX 1; SCREW, FIXATION, BONE

Model Number	7207561
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/02/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while engaging the screw in the tibial side during insertion, the screw broke at the tip.No patient injury was reported.
Additional Manufacturer Narrative
Examination was not possible, as the device has not been returned.The investigation could not draw any conclusions about the reported event without the return of the device.
Additional Manufacturer Narrative
One 8x30mm biorci screw was returned for evaluation.Visual assessment of the screw confirmed the reported complaint of breakage.Approximately 4mm off the distal threads have broken off.Dimensional assessment of the screws major diameter and wall thickness was performed and found to meet print specifications.Clinical details were reported that no starter was utilized.The starter must be utilized with the biorci screws to minimize screw breakage during insertion.

• Brand Name: SCR BIORCI 8X30MM STRL BX 1
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7449509
• Report Number: 1219602-2018-00467
• Device Sequence Number: 1637040
• Product Code: HWC
• UDI-Device Identifier: 03596010426239
• UDI-Public: (01)03596010426239(17)201022(10)50570981
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/21/2018

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: 10/22/2020
• Device Model Number: 7207561
• Device Catalogue Number: 7207561
• Device Lot Number: 50570981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2018
• Initial Date Received by Manufacturer: 04/03/2018
• Supplement Date Received by Manufacturer: 05/16/2018; 08/20/2018
• Initial Report FDA Received Date: 04/21/2018
• Supplement Report FDA Received Date: 05/21/2018; 08/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1