MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI-HA 7X25 8MM HEAD R THR STER; SCREW, FIXATION, BONE

Model Number	7209023
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the screw (biorci-ha 7x25mm/8mm) broke into pieces while being advanced into femoral tunnel.Surgeon made all effort to remove bits and pieces of screw, but none was retrieved for sampling.Screw tap on-site, did not used.Surgeon ended up using rci screw for the femur instead.Screw implanted successfully, procedure completed without any other incident.
Additional Manufacturer Narrative
Due no product return, the complaint could not be confirmed.Definitive conclusions cannot be made without a device to evaluate.Accurate investigation and evaluation are not possible.The product met specifications upon release to distribution.No further actions pursued at this time.If relevant information becomes available to assist with evaluation, the complaint will certainly be revisited.

• Brand Name: SCR BIORCI-HA 7X25 8MM HEAD R THR STER
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7059842
• Report Number: 1219602-2017-01475
• Device Sequence Number: 2145023
• Product Code: HWC
• UDI-Device Identifier: 03596010460080
• UDI-Public: (01)03596010460080(17)220407(10)50657542
• Combination Product (Y/N): N
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/07/2022
• Device Model Number: 7209023
• Device Catalogue Number: 7209023
• Device Lot Number: 50657542
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/27/2017
• Supplement Date Received by Manufacturer: 11/27/2017
• Initial Report FDA Received Date: 11/27/2017
• Supplement Report FDA Received Date: 01/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 19 YR