MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI-HA 7X20 7MM HEAD STERILE; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	7207686
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/31/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a acl reconstruction surgery, the screw broke.The broken pieces were removed from the patient.A same model backup device was used to complete the surgery with no significant delay or patient injuries.
Additional Manufacturer Narrative
One sterile 7207686 7x205mm biorci-ha screw returned.The complaint stated: "during a acl reconstruction surgery, the screw broke." dimensional inspection verifies that this is a 9x25mm product.The date of occurrence is listed as( b)(6) 2018.The expiration date on the product carton and foil pouch labels indicate (b)(4) 2018.This would calculate that the product had expired nearly three months prior to the procedure.The screw was returned quite bio tainted but otherwise in reasonably good condition.The product returned shows no signs of breakage or fracture.The screw is whole.There is no stripping of the head.The stated allegation does not appear to be aligned with the physical return.No root cause related to the manufacturing of this device was confirmed.

• Brand Name: SCR BIORCI-HA 7X20 7MM HEAD STERILE
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7776290
• Report Number: 1219602-2018-01039
• Device Sequence Number: 1318908
• Product Code: MAI
• UDI-Device Identifier: 03596010459909
• UDI-Public: (01)03596010459909(17)180430(10)50459552
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K002274
• 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
• Report Date (Section B): 10/03/2018

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: 04/30/2018
• Device Model Number: 7207686
• Device Catalogue Number: 7207686
• Device Lot Number: 50459552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 08/13/2018
• Supplement Report FDA Received Date: 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1