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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 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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WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPUY SYNTHES HAMMERTOE CCI STD KIT W/1.25 K-WIRE/ STERILE; STAPLE, FIXATION, BONE Back to Search Results
Catalog Number 46.239.001
Device Problems Device-Device Incompatibility (2919); Appropriate Term/Code Not Available (3191)
Patient Problems Failure of Implant (1924); No Code Available (3191)
Event Date 07/30/2020
Event Type  Injury  
Manufacturer Narrative
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.
 
Event Description
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).
 
Manufacturer Narrative
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.
 
Event Description
This report is for one (1) depuy synthes hammertoe cci std kit w/1.25 k-wire / sterile.
 
Manufacturer Narrative
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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Brand Name
DEPUY SYNTHES HAMMERTOE CCI STD KIT W/1.25 K-WIRE/ STERILE
Type of Device
STAPLE, FIXATION, BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key10449428
MDR Text Key204261797
Report Number2939274-2020-03779
Device Sequence Number1
Product Code JDR
Combination Product (y/n)N
PMA/PMN Number
K191463
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 07/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number46.239.001
Was Device Available for Evaluation? No
Date Manufacturer Received09/24/2020
Patient Sequence Number1
Treatment
HAMMERLOCK 2 IMPLANT KIT 12X5MM/0 DEGREES/SMALL; HAMMERLOCK 2 IMPLANT KIT 12X5MM/0 DEGREES/SMALL; HAMMERLOCK 2 IMPLANT KIT 15X5MM/0 DEGREES/MEDIUM; UNK - BONE STAPLE: HAMMERLOCK 2; UNK - DRILL; HAMMERLOCK 2 IMPLANT KIT 12X5MM/0 DEGREES/SMALL; HAMMERLOCK 2 IMPLANT KIT 12X5MM/0 DEGREES/SMALL; HAMMERLOCK 2 IMPLANT KIT 15X5MM/0 DEGREES/MEDIUM; UNK - BONE STAPLE: HAMMERLOCK 2; UNK - DRILL
Patient Outcome(s) Required Intervention;
Patient Age43 YR
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