MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI 8X25MM STRL BX 1; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	7207560
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure when the screw was placed, this broke.The screw was not completely placed when it broke.The damage part was removed completely and the procedure was completed by using another of the same smith & nephew device.No damage to the patient due to the incident that was reported since the piece was removed without problem.The patient´s health condition is stable.
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.(b)(6).
Additional Manufacturer Narrative
One 8x25 mm biorci screw was returned for evaluation.Visual assessment of the screw confirmed the reported breakage.Approximately 5mm of the distal threads have broken off and were not returned for examination.Dimensional assessment of the screws major diameter and wall thickness was performed and found to meet print specifications.This investigation could not identify any evidence of product contribution to the reported complaint.

• Brand Name: SCR BIORCI 8X25MM STRL BX 1
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7765285
• Report Number: 1219602-2018-01002
• Device Sequence Number: 16631851
• Product Code: MAI
• UDI-Device Identifier: 03596010426222
• UDI-Public: (01)03596010426222(17)211111(10)50630954
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K992396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/12/2018

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: 11/11/2021
• Device Model Number: 7207560
• Device Catalogue Number: 7207560
• Device Lot Number: 50630954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Initial Date Received by Manufacturer: 07/27/2018
• Supplement Date Received by Manufacturer: 09/11/2018; 09/25/2018
• Initial Report FDA Received Date: 08/08/2018
• Supplement Report FDA Received Date: 09/12/2018; 09/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1