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

Model Number	014407
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem 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.
Additional 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.The batch number of the packaging this was found in was not found.A visual inspection revealed that the package had not been opened, and the seals did not contain any voids or problems.On this package, however, the top film had been sliced through.It is assumed that this occurred in transit to the evaluation center, as a similar slice was noted on the paper covering the package and the exterior zip bag.There was a small blue fiber in the packaging the matched the color and sheen of the nylon strap.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)
• Common Device Name: COMPONENT, TRACTION, NON-INVASIVE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11100324
• Report Number: 1219602-2020-02212
• Device Sequence Number: 3781195
• Product Code: KQZ
• UDI-Device Identifier: 03596010095329
• UDI-Public: 03596010095329
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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): 03/12/2021

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: 06/03/2025
• Device Model Number: 014407
• Device Catalogue Number: 014407
• Device Lot Number: 2056656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 12/31/2020
• Supplement Report FDA Received Date: 03/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1