MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI-HA 7X20 7MM HEAD STERILE; SCREW, FIXATION, BONE

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 was broken when using.The broken pieces were removed from the patient, and a smith & nephew backup device was used to complete succesfully the surgery with no significant delay.No patient injuries reported.
Additional Manufacturer Narrative
One 7x20mm biorci ha screw was returned for evaluation.The screw was returned in five pieces of varying sizes confirming the reported breakage.Dimensional assessment is prohibitive due to its condition.The condition of the screw suggests it was subjected to excessive force during insertion.

• Brand Name: SCR BIORCI-HA 7X20 7MM HEAD STERILE
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7810760
• Report Number: 1219602-2018-01120
• Device Sequence Number: 19194983
• Product Code: HWC
• 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: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2018

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: 207686
• 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: 09/25/2018
• Initial Report FDA Received Date: 08/23/2018
• Supplement Report FDA Received Date: 09/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 88