MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIORCI SCRW 7MM(7MM HD)X20MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	7207916
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/04/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the tip of the screw broke.
Additional Manufacturer Narrative
Added operator of device device investigation narrative - one (b)(4) sterile biorci 7x20mm screw returned.The product is used.The procedure was only listed as ¿surgery¿.Dimensional inspection verifies that this is a 7x20mm product.The screw is two years old.The head and upper threads are in good condition.The damage is of the distal tip.Complaint indicates that the screw broke while being passed through the guide.The damage is consistent with contact of another device or instrument.The threads have a tear-like sever from the distal direction toward the head.This also indicates force contributed.There is a 7.15mm portion of material missing in the screw¿s length due to damage.This portion was not returned.Surgical prep details were not available.It is unknown whether the ifu warning was followed: ¿the starter must be utilized with the biorci screws to minimize screw breakage during insertion¿.This product also requires use of a tap for hard bone densities.No further investigation is warranted.No root cause related to the manufacturing of this device can be confirmed.Device returned for evaluation device evaluated by the manufacturer evaluation codes updated c-(b)(4).

• Brand Name: BIORCI SCRW 7MM(7MM HD)X20MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 6839937
• Report Number: 1219602-2017-01061
• Device Sequence Number: 460841
• Product Code: MAI
• UDI-Device Identifier: 03596010000897
• UDI-Public: (01)03596010000897(17)210203(10)50585485
• Combination Product (Y/N): N
• PMA/510(K) Number: K032224
• 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
• Report Date (Section B): 09/28/2017

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: 02/03/2021
• Device Model Number: 7207916
• Device Catalogue Number: 7207916
• Device Lot Number: 50585485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2017
• Initial Date Received by Manufacturer: 08/08/2017
• Supplement Date Received by Manufacturer: 09/27/2017
• Initial Report FDA Received Date: 09/01/2017
• Supplement Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 31 YR