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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH DRILL TIP FIXATION PIN STAR ANKLE 2.4MM X 80MM; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME
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STRYKER GMBH DRILL TIP FIXATION PIN STAR ANKLE 2.4MM X 80MM; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME Back to Search Results
Catalog Number 9330018
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/14/2018
Event Type  malfunction  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
It was reported by stryker rep that during a ankle prothesis surgery, the surgeon encounter restistance while trying to pass the pins (933-0018) through the talar window trial (926-0062).The first pin enter with resistance.The second one broke and a part was blocked into the patient.The surgeon was able to remove the pins and used screws instead of the pins to complete the surgery.The surgery was completed successfully, the surgical delay was less the 15 minutes.He stated that the pins passed successfully in an other talar window trial of the kit but not in the 926-0062.
 
Event Description
It was reported by stryker rep that during a ankle prothesis surgery, the surgeon encounter restistance while trying to pass the pins (933-0018) through the talar window trial (926-0062).The first pin enter with resistance.The second one broke and a part was blocked into the patient.The surgeon was able to remove the pins and used screws instead of the pins to complete the surgery.The surgery was completed successfully, the surgical delay was less the 15 minutes.He stated that the pins passed successfully in an other talar window trial of the kit but not in the 926-0062.
 
Manufacturer Narrative
The reported event of non-mating instruments (drill / trial) and breakage was confirmed.No deviations were found during review of the manufacturing and inspection documents (dhr).The drills were documented as faultless prior to distribution.No deficiency found during dimensional inspection of the returned product.The shaft of the returned drill had become damaged by contact with the damaged drill holes in the trial ¿ ether by pre-damaged trial or during the procedure of mal-aligned drilling.The damage patterns indicate that the broken instrument was operated in counter-clockwise direction (unscrewing) under high torsional force application whilst the squares became broken.This was caused during operating in left direction after the drill had stuck and in order to remove the drill.Summarizing above findings the event was caused by unsuitable handling by the user.Review of complaint history, capa databases and risk analysis did not identify any conspicuity.The review of the risk assessment for the failure mode indicated the issue was addressed adequately.There were no actions in place related to the reported event for the subject product.No similar complaint has been reported within the same lot # l36122.No non-conformity was identified.The event was not linked to a deficiency of the device.
 
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Brand Name
DRILL TIP FIXATION PIN STAR ANKLE 2.4MM X 80MM
Type of Device
PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
MDR Report Key7329321
MDR Text Key102115879
Report Number0008031020-2018-00167
Device Sequence Number1
Product Code NTG
Combination Product (y/n)N
PMA/PMN Number
P050050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 07/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number9330018
Device Lot NumberL36122
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/26/2018
Date Manufacturer Received06/05/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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