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

Model Number 7207248

Device Problems Packaging Problem (3007); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/08/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event 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.

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
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 12083371
• MDR Text Key: 258888452
• Report Number: 1219602-2021-01446
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 03596010375353
• UDI-Public: 03596010375353
• Combination Product (y/n): N
• PMA/PMN Number: K992945
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1