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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL IM REAMER, MOD. TRINKLE FITTING BIXCUT Ø10,5X480MM; INSTRUMENT
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STRYKER TRAUMA KIEL IM REAMER, MOD. TRINKLE FITTING BIXCUT Ø10,5X480MM; INSTRUMENT Back to Search Results
Catalog Number 02276105
Device Problems Break (1069); Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/25/2019
Event Type  malfunction  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
The surgeon reported that during the case the 10.5 flexible reamer was used and the tip broke off leaving a piece in the femoral canal.Attempts were made to remove the piece but were unsuccessful.The case was completed as the piece was sufficiently far down the canal that the implant could still be placed over the top.The surgeon stated that the device is not cannulated and, as a result, it is more difficult to remove the item if it breaks because of this design feature.
 
Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches with the alleged failure.Visual inspection revealed that the received bixcut im reamer was completely broken at the tip.Coil of flexible shaft was heavily deformed and squizzed near breaking point, most likely due to torsional overload during rotation in clockwise direction.No further damage was observed.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The operative technique instructs user that ¿reaming is commenced with the flexible shaft equipped with a small size reamer head.Continue the procedure in 0.5mm increments until cortical contact is appreciated.¿ based on the investigation, root cause of failure could be attributed to user related issue.Failure was caused due to torsional overload during rotation in clockwise direction.The reason for the torsion overloads could not be determined but most likely the reamer bixcut heads got stuck in the marrow channel during reaming.It is possible that the customer tried to open the marrow channel with increments more than 0.5mm.Due to a too thin channel the reamer got jammed.If any further information is provided, the complaint report will be updated.
 
Event Description
The surgeon reported that during the case the 10.5 flexible reamer was used and the tip broke off leaving a piece in the femoral canal.Attempts were made to remove the piece but were unsuccessful.The case was completed as the piece was sufficiently far down the canal that the implant could still be placed over the top.The surgeon stated that the device is not cannulated and, as a result, it is more difficult to remove the item if it breaks because of this design feature.
 
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Brand Name
IM REAMER, MOD. TRINKLE FITTING BIXCUT Ø10,5X480MM
Type of Device
INSTRUMENT
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
MDR Report Key8359063
MDR Text Key137055420
Report Number0009610622-2019-00077
Device Sequence Number1
Product Code MAY
UDI-Device Identifier04546540145857
UDI-Public04546540145857
Combination Product (y/n)N
PMA/PMN Number
K153345
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 04/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number02276105
Device Lot NumberK0A176D
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/07/2019
Date Manufacturer Received04/02/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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