SMITH & NEPHEW, INC. BONE ANCHORS 3 W ARTHRO DEL SYSTEM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Model Number 2503-A |
Device Problems
Break (1069); Difficult to Insert (1316); Connection Problem (2900); Material Twisted/Bent (2981); Positioning Problem (3009)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/13/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that, during surgery, the inserter was not loading the anchors from the puck correctly and a the anchor broke.Although a back-up device was available to complete the procedure, it is unknown if there was a surgery delay.No further complications were reported.
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Manufacturer Narrative
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Internal complaint reference (b)(4).
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Manufacturer Narrative
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H10: internal complaint reference: case-(b)(4).Correction in d1, d2, d4 (catalog & udi no's), g4 (510k) & h6 (medical device problem code).
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Manufacturer Narrative
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Internal complaint reference (b)(4).Correction in h6 (medical device problem code).
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Manufacturer Narrative
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H10: h2: additional information on: b5 & e1.H3, h6: the reported device was received for evaluation.A visual inspection found that one of the tines are slightly bent.A functional evaluation revealed that the device can not properly load a tendon anchor due to the bent tine.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.The root cause has been associated with unintended use of the device.Factors that could have contributed to the reported event include excessive force on the device, excessive torque on the device tip, attempted correction of a damaged device, or an inadvertent impact event.No containment or corrective actions are recommended at this time.H11: h2: corrected data on: d1, d2a, d4, g4, h4 & h6 (health effect - impact code).
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Event Description
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It was reported that, during a revision rcr surgery, the tendon anchor inserter was not loading the anchors from the puck correctly.The procedure was successfully completed with a 30 minutes surgical delay using a back-up device.No further complications were reported.
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Search Alerts/Recalls
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