MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR RCI 8X25 STER; SCREW, FIXATION, BONE

Model Number	7207248
Medical Device Problem Codes	Packaging Problem (3007); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during the set up of a btb acl reconstruction, surgeon requested a scr rci 8x25 screw, and when taking the packaging out from the box, it was noticed that there was a small hole in the sterile package.Procedure finished with s&n backup device.Surgical delay of less than or equal to 30 minutes.No further complications to patient were reported.
Additional Manufacturer Narrative
H10: h3, h6: the reported device, intended for use in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was an isolated event.A review of the print specifications found that the pouches must be free of nicked or frayed edges.Pouches must be clean and free of foreign particles.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: SCR RCI 8X25 STER
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 12083371
• Report Number: 1219602-2021-01446
• Device Sequence Number: 19800894
• Product Code: HWC
• UDI-Device Identifier: 03596010375353
• UDI-Public: 03596010375353
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K992945
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2021

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: 11/01/2023
• Device Model Number: 7207248
• Device Catalogue Number: 7207248
• Device Lot Number: 2062733
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 08/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1