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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 11,0X480MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
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STRYKER TRAUMA KIEL IM REAMER, MOD. TRINKLE FITTING BIXCUT 11,0X480MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS Back to Search Results
Model Number 0227-6110
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/03/2021
Event Type  malfunction  
Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
 
Event Description
It was reported that during a right antegrade gtn nail implantation, the reamer broke off inside the intramedullary canal.The part was retrieved by removing the ball-tipped guide wire it was attached to.No pieces remained in the patient.Rep can provide pictures, and otherwise confirmed that no further information will be released by the hospital or surgeon.
 
Event Description
It was reported that during a right antegrade gtn nail implantation, the reamer broke off inside the intramedullary canal.The part was retrieved by removing the ball-tipped guide wire it was attached to.No pieces remained in the patient.Rep can provide pictures, and otherwise confirmed that no further information will be released by the hospital or surgeon.
 
Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure.The device inspection revealed the following: the im reamer was received with its reamer head detached from the spiral.Spiral and the cutting edges, overall, looked in alright state.However, the point of detachment shows signs of excessive rotation and slight burn mark due to generated heat during use.The manner of detachment and deformation indicates towards torsional overload.The head shaft diameter of the reamer was observed to be 6.48mm against the required diameter in the range of 6.40mm to 6.60mm.Similarly, the average hardness of the drill was observed to be 50.4 hrc against the required hardness in the range of 46.0hrc to 50.0hrc.As per the dimensional inspection and hardness testing, the returned reamer was found to be within specifications.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.Based on the investigation the root cause of the failure was determined to be user related.It is a case of a forced breakage of the reamer due to torsional overload.The reason for the torsion overloads could not be determined but most likely the reamer head got stuck in the marrow channel during reaming.Due to a too thin channel the reamers got jammed.The operative technique includes that reaming should be done in 0.5mm increments until cortical contact is appreciated.If any additional information is provided, the investigation will be reassessed.
 
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Brand Name
IM REAMER, MOD. TRINKLE FITTING BIXCUT 11,0X480MM
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM  D-24232
MDR Report Key11215555
MDR Text Key228241416
Report Number0009610622-2021-00242
Device Sequence Number1
Product Code MAY
UDI-Device Identifier04546540145864
UDI-Public04546540145864
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 04/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0227-6110
Device Catalogue Number02276110
Device Lot NumberK0E99A7
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/12/2021
Initial Date Manufacturer Received 01/03/2021
Initial Date FDA Received01/22/2021
Supplement Dates Manufacturer Received04/06/2021
Supplement Dates FDA Received04/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age17 YR
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