MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI 7X30MM (8MM HEAD) STRL BX 1; SCREW, FIXATION, BONE

Model Number	7207558
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 the tip of screw broke at the femur.A backup device was available to complete the procedure with no significant delay or patient injuries.
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 7x30mm biorci screw w/8mm head was returned for evaluation.Visual assessment of the screw confirmed the reported complaint of breakage.Approximately 3mm of the distal threads have broken off and were not returned for examination.Dimensional assessment of the screws major diameter and wall thickness was found to meet print specification.It is difficult to perform an accurate evaluation of a failure without having the entire product and the pertinent clinical details to consider.As such the complaint is being closed without conclusion.

• Brand Name: SCR BIORCI 7X30MM (8MM HEAD) STRL BX 1
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7481944
• Report Number: 1219602-2018-00519
• Device Sequence Number: 18858169
• Product Code: HWC
• UDI-Device Identifier: 03596010426215
• UDI-Public: (01)03596010426215(17)190918(10)50520261
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: K992396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/20/2018

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: 7207558
• Device Catalogue Number: 7207558
• Device Lot Number: 50520261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Initial Date Received by Manufacturer: 04/15/2018
• Supplement Date Received by Manufacturer: 05/29/2018; 11/16/2018
• Initial Report FDA Received Date: 05/02/2018
• Supplement Report FDA Received Date: 05/30/2018; 11/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1