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

Model Number 7207607

Device Problem Material Disintegration (1177)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/19/2018

Event Type  malfunction  

Event Description

It was reported that the screw was found disintegrated when it was trying to screw it in.No patient injury reported.

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.

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)
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7227652
• MDR Text Key: 98738934
• Report Number: 1219602-2018-00170
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 03596010426307
• UDI-Public: (01)03596010426307(17)190918(10)50520253
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K992396
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2018
• Initial Date FDA Received: 01/30/2018
• Supplement Dates Manufacturer Received: 01/19/2018; 06/04/2018
• Supplement Dates FDA Received: 03/02/2018; 06/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1