MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI-HA 11X30 STERILE; SCREW, FIXATION, BONE

Catalog Number	7209014
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an acl reconstruction the screw got broken inside the patient's anatomy, all the broken pieces were removed.No patient injuries or delay reported.Back-up device was available to complete the surgery.
Event or Problem Description
It was reported that during an acl reconstruction the screw got broken inside the patient's anatomy, all the broken pieces were removed.No patient injuries or significant delay reported.Back-up device was available to complete the surgery.
Additional Manufacturer Narrative
One 11x30mm biorci ha screw was returned for evaluation.Visual assessment of the screw could not confirm the reported breakage as the screw is intact.Dimensional assessment of the screw confirmed it met print specifications.

• Brand Name: SCR BIORCI-HA 11X30 STERILE
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8762788
• Report Number: 1219602-2019-00781
• Device Sequence Number: 16785572
• Product Code: HWC
• UDI-Device Identifier: 03596010460189
• UDI-Public: 03596010460189
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2019

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: 01/04/2024
• Device Catalogue Number: 7209014
• Device Lot Number: 50779646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Initial Date Received by Manufacturer: 06/16/2019
• Supplement Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 07/04/2019
• Supplement Report FDA Received Date: 07/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1