MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FOOT STRAP ANKLE DSTRCTR STRL(6); COMPONENT, TRACTION, NON-INVASIVE

Model Number 014407

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 12/09/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during the surgery it was found a foreign matter inside the sterile ankle distractor foot straps package.No patient injuries or delay reported.Unknown if there was a back-up device to complete the surgery.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10: h3,h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.An analysis of the customer provided images found thin blue fibers in the packaging that matched the coloring and thread size of the nylon strap.A visual inspection revealed that the package had not been opened, and the seals did not contain any voids or problems.There was a small black plastic sliver in the package.Upon opening the package, multiple barely visible slivers were found.They appeared to be from the flashing of black nylon snap hook.Closer inspection revealed that the flashing of the hook was peeling off at the end.A review of the device 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 a repeat issue.A review of the drawing found that packages must be free of particulates.The complaint was confirmed and the root cause was associated with transport.Factors that could have contributed to the reported event include excess rubbing or jostling in transport, tough shipping and handling, or an impact event.

• Brand Name: FOOT STRAP ANKLE DSTRCTR STRL(6)
• Type of Device: COMPONENT, TRACTION, NON-INVASIVE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11100316
• MDR Text Key: 224528134
• Report Number: 1219602-2020-02209
• Device Sequence Number: 1
• Product Code: KQZ
• UDI-Device Identifier: 03596010095329
• UDI-Public: 03596010095329
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 014407
• Device Catalogue Number: 014407
• Device Lot Number: 2057099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Date Manufacturer Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1