MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPS POST-OP VISIBLE 10.5X9CM JP CTN 20; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED

Catalog Number 66800143

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 10/28/2021

Event Type  malfunction  

Event Description

It was reported that, when a sterile pouch of an ops post-op visible 10.5x9cm jp ctn 20 was taken out from the carton, it was confirmed the pouch has been opened due to no sealing on one side edge.As this was noticed in a non-therapeutic environment, there was not any patient involved.

Manufacturer Narrative

Internal reference number: (b)(4).

Manufacturer Narrative

H3, h6: the device was returned for evaluation.A visual inspection of the returned device confirmed open seal on one side of the pouch, establishing a relationship between the device and the reported event.A failed in-process inspection has been identified as the root cause.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.The complaint history review found no further instances of the reported event.The risk files mitigate the reported issue with no updates required.Training was delivered to operators to keep vigilant during in-process inspection.This investigation is now complete with no further action deemed necessary.Smith and nephew will continue to monitor for any adverse trends relating to this product range.

• Brand Name: OPS POST-OP VISIBLE 10.5X9CM JP CTN 20
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin; austin, TX 78735 ; 5123913905
• MDR Report Key: 12827405
• MDR Text Key: 280876368
• Report Number: 8043484-2021-01959
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 05000223468705
• UDI-Public: 5000223468705
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2024
• Device Catalogue Number: 66800143
• Device Lot Number: 202115
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1