STRYKER ENDOSCOPY-SAN JOSE ICONIX 1 NEEDLES WITH INTELLIBRAID TECHNOLOGY, 1.4MM ANCHOR WITH 1.2MM XBRAID TT; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Catalog Number 3910500212 |
Device Problems
Break (1069); Difficult to Remove (1528)
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Patient Problems
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/24/2022 |
Event Type
Injury
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Event Description
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It was reported that the tip of the inserter broke during the procedure and remained in the patient.
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
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Manufacturer Narrative
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This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: inserter tip broken off probable root cause: design inserter/implant not compatible with guide inserter material/design too weak inserter shaft cannot bend around curved guide drill not designed to center hole with respect to guide mouth not designed to grip bone guide not able to be gripped tightly process inserter, implant, and/or guide manufactured out of spec anchor coating process out of specification application excessive force impacting inserter movement of guide out of orientation to pilot hole use of wrong drill the reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.H3 other text : 81.
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Event Description
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It was reported that the tip of the inserter broke during the procedure and remained in the patient.
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Search Alerts/Recalls
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