MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PIGGY BACK (2); ACCESSORIES, OPERATING-ROOM, TABLE (KIT)

Model Number	7210570
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, the account ordered two "spider piggy backs".The product was received in a brown box with a s+n label; however, the product found inside was a "spider foot traction connector".It is unknown whether the event happened during surgery or if there was a patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported device, intended for use in treatment, was not returned to the designated complaint facility for independent evaluation, thus visual inspection and functional testing could not be performed.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 the customer provided images found an invoice and two incorrect devices from batch 3551 that were received in a brown box with a s+n label.A quality engineering review was performed.The product received by the customer was determined to be an ankle arthroscopy accessory (pn 72202935 batch 3551) manufactured in october 2014.A review of inventory was conducted, and no inventory of the complaint batch remained in stock.Neither unit, 7210570 nor 72202932, returns to s+n okc for service so there is no cause for the units to have ever been back at okc during the same time.The complaint was confirmed and the root cause can be attributed to a manufacturing error.A review of the piggy back final inspection process summary found instructions to properly package two piggy back connectors into a single box.Manufacturing quality was notified of the reported event and conducted an investigation into the matter.Internal complaint reference: case-2021-00047698-1.
Additional Manufacturer Narrative
H10, h3, h6: the reported device was received for evaluation.A product evaluation was performed on the product.The two devices received were not piggyback connectors.It was determined the device contributed to the reported event.A review of the customer provided images found an invoice and two incorrect devices from batch 3551 that were received in a brown box with a s+n label.A quality engineering review was performed.The product received by the customer was determined to be an ankle arthroscopy accessory (pn 72202935 batch 3551) manufactured in october 2014.A review of inventory was conducted, and no inventory of the complaint batch remained in stock.Neither unit, 7210570 nor 72202932, returns to s+n okc for service so there is no cause for the units to have ever been back at okc during the same time.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the packaging assembly found that instructions to properly package two piggy back connectors into a single box.The root cause can be attributed to a manufacturing error.A review of the piggy back final inspection process summary found instructions to properly package two piggy back connectors into a single box.Manufacturing quality was notified of the reported event and conducted an investigation into the matter.No further containment or corrective actions are recommended at this time.

• Brand Name: PIGGY BACK (2)
• Common Device Name: ACCESSORIES, OPERATING-ROOM, TABLE (KIT)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11646603
• Report Number: 1643264-2021-01345
• Device Sequence Number: 3099413
• Product Code: FWZ
• UDI-Device Identifier: 03596010511218
• UDI-Public: 03596010511218
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2023

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 Model Number: 7210570
• Device Catalogue Number: 7210570
• Device Lot Number: 6164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 07/14/2021; 11/06/2023
• Initial Report FDA Received Date: 04/10/2021
• Supplement Report FDA Received Date: 07/20/2021; 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown