MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ECTRA PROCEDURE KIT; ARTHROSCOPE

Model Number	4116
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during unknown procedure, outside the patient, it was found a black foreign material into the ectra procedure kit.The procedure was finished with a smith and nephew backup device.10 minutes of surgical delay.Patient injuries were not reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).The reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A review of workmanship standard, includes specification on the acceptable size of particles in sterile packaging.A visual inspection revealed the kit was returned opened and missing the items in the kit with exception of the hand pad which appeared to have a piece of black suture attached.A review of the customer provided image reveals what appears to be a black speck or writing on the hand pad of the procedure kit.The complaint was confirmed.Factors that could have caused or contributed include contamination while opening.No containment or corrective actions are recommended at this time.

• Brand Name: ECTRA PROCEDURE KIT
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 11850156
• Report Number: 1643264-2021-01905
• Device Sequence Number: 3766910
• Product Code: HRX
• UDI-Device Identifier: 03596010122148
• UDI-Public: 03596010122148
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K954627
• 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): 06/22/2021

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: 10/25/2023
• Device Model Number: 4116
• Device Catalogue Number: 4116
• Device Lot Number: 50901603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2021
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 06/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1