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

Model Number	7207607
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/19/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the screw was found disintegrated when it was trying to screw it in.No patient injury 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.A review of the ncmr database was performed which confirmed no abnormalities were reported with this lot during manufacture.A complaint history review identified no additional complaints for this manufactured lot.
Additional Manufacturer Narrative
One 7x25mm biorci reverse thread screw was returned for evaluation.Visual assessment of the screw confirmed the reported complaint of breakage.Approximately 5mm of the distal threads have broken off.The broken portion was returned in three pieces of varying sizes.Dimensional assessment of the screws major diameters and wall thickness was performed and found to be within print specifications.Due to the limited clinical details provided we are unable to provide a root cause for this failure.This investigation could not identify any evidence of product contribution to the reported complaint.

• Brand Name: SCR.BIORCI REV THRD 7X25MM (8MM HEAD)
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7227652
• Report Number: 1219602-2018-00170
• Device Sequence Number: 11105678
• Product Code: HWC
• UDI-Device Identifier: 03596010426307
• UDI-Public: (01)03596010426307(17)190918(10)50520253
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K992396
• 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,Followup
• Report Date (Section B): 06/05/2018

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: 09/18/2019
• Device Model Number: 7207607
• Device Catalogue Number: 7207607
• Device Lot Number: 50520253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Initial Date Received by Manufacturer: 01/19/2018
• Supplement Date Received by Manufacturer: 01/19/2018; 06/04/2018
• Initial Report FDA Received Date: 01/30/2018
• Supplement Report FDA Received Date: 03/02/2018; 06/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1