WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPUY SYNTHES HAMMERTOE CCI STD KIT W/1.25 K-WIRE/ STERILE; STAPLE, FIXATION, BONE
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Catalog Number 46.239.001 |
Device Problems
Device-Device Incompatibility (2919); Appropriate Term/Code Not Available (3191)
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Patient Problems
Failure of Implant (1924); No Code Available (3191)
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Event Date 07/30/2020 |
Event Type
Injury
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Manufacturer Narrative
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Pma/510k: this report is for an unknown bone staple: hammerlock 2/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that on (b)(6) 2020, during a hammertoe correction on digits 2-5 the inserter for the hammertoe cci would not release.The first inserter was tried and when it did not work, the surgeon drilled again to make sure that it went all the way to the drill stop.When drilling did not work, the surgeon looked at it on the back table and eventually managed to release the implant from the inserter.The surgeon then opened another implant but the new implant did not release either.When the hammertoe cci did not work, a hammerlock 2 cci was tried.The surgeon attempted to use a medium hammerlock implant on the second digit and successfully inserted the cci in the proximal phalange.However, the surgeon could not get the intermediate and distal phalange up and on the distal end of the cci.A small hammerlock implant was tried, and still had the same results.The surgeon then put a k-wire in.A small hammerlock 2 cci was tried on the second digit but had the same results.The surgeon then put k-wires in the rest of the digits.The surgeon decided to use k-wires.The procedure was successfully completed with a thirty (30) minute surgical delay.Patient status is unknown.Concomitant device reported: drill (part number unknown, lot unknown, quantity 1), hammerlock 2 implant kit 12x5mm/0 degrees/small (part number hl2s, lot unknown, quantity 2), hammerlock 2 implant kit 15x5mm/0 degrees/medium (part number hl2m, lot unknown, quantity 1), bone staple: hammerlock 2 (part number unknown, lot unknown, quantity 2).This report involves one (1) bone staple: hammerlock 2.This is report 5 of 5 for (b)(4).
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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This report is for one (1) depuy synthes hammertoe cci std kit w/1.25 k-wire / sterile.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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