ZIMMER BIOMET, INC. JUGGERSTITCH CURVED IMPLANT; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE/SPORTS MEDICINE
|
Back to Search Results |
|
Model Number 110024773 |
Device Problems
Fracture (1260); Activation, Positioning or Separation Problem (2906)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/23/2022 |
Event Type
malfunction
|
Event Description
|
It was reported that the surgeon had difficulty inserting the needle into the patient's meniscus.Once the surgeon was able to do this, the instrument failed to deploy the anchor and needle was detached from the device.No patient injury has been reported as a result of the malfunction.
|
|
Manufacturer Narrative
|
(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|
|
Manufacturer Narrative
|
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; g6; h1; h2; h3; h6 visual examination of the returned product identified the product has been cycled twice.The suture lines are free from the device and there is one suture line that has nothing attached and there is one that has the fractured needle tip and anchor.It is confirmed the needle tip has fractured and all the pieces were returned.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Search Alerts/Recalls
|
|
|