FOOTPRINT MINI PK 3.5MM
Received Jul 31, 2026 · Event occurred Jul 3, 2026
Report 1219602-2026-02417 · MDR key 50107104
Device
Generic name
Fastener, Fixation, Nondegradable, Soft Tissue
Manufacturer
Smith & Nephew, Inc.Catalog number
72205687
Lot number
2204388
Product problems
- Unintended Movement
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that the tape of one (1) FOOTPRINT MINI PK 3.5MM slid and failed to lock in place. It is unknown whether this problem was noticed in a surgical environment or not; therefore, patient involvement has not been confirmed.
Additional Manufacturer Narrative
H11: Internal Complaint Reference: CASE-(b)(4).H3, H6: This complaint was opened by Smith+Nephew to document a product problem associated with a Smith+Nephew device.The reported problem relates to known risks with the device itself or with its use that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.