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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 10,0X480MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
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STRYKER TRAUMA KIEL IM REAMER, MOD. TRINKLE FITTING BIXCUT 10,0X480MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS Back to Search Results
Model Number 0225-6100
Device Problem Unraveled Material (1664)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/08/2020
Event Type  malfunction  
Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.
 
Event Description
The stryker sales representative reported that whilst supporting a t2 proximal humeral nail case and during reaming the humerus with a flexible reamer, the reamer shaft uncoiled within the patient.The situation was rectified.The hospital staff explained there was a user error due to the surgeon withdrawing the reamer on reverse power rather than forward.The distal part of the reamer that had uncoiled most prominently caught on the fracture site making extraction very difficult.This added around 20-30 minutes to the surgical time.No residual metal was left in the patient.The reamer shaft was detached from the power tool handpiece and rotated gently by hand, uncoiling the reamer.This allowed the reamer to pass by the fracture site without catching and to be pulled back out through the entry site.
 
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 in a dilapidated state with the spiral in a severely unwound state at multiple location.It was evident that the reamer was rotated in a counter-clockwise direction.The spiral was also found to be broken from the point where it is welded with the adapter.Around that region, burn mark can be seen which is a sign of excessive restricted rotation up to a point of heat generation.The cutting flutes showed normal signs of usage.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.During the surgery the reamer was rotated in a counterclockwise direction which is an off-label use.Consequently, the reamer uncoiled inside the patient and led to further damage of the instrument.The instruction for use clearly suggests the user that: ¿never operate an intramedullary reamer in a counterclockwise direction.Doing so causes the reamer shaft spiral to open and may lead to additional trauma.¿ if any additional information is provided, the investigation will be reassessed.
 
Event Description
The stryker sales representative reported that whilst supporting a t2 proximal humeral nail case and during reaming the humerus with a flexible reamer, the reamer shaft uncoiled within the patient.The situation was rectified.The hospital staff explained there was a user error due to the surgeon withdrawing the reamer on reverse power rather than forward.The distal part of the reamer that had uncoiled most prominently caught on the fracture site making extraction very difficult.This added around 20-30 minutes to the surgical time.No residual metal was left in the patient.The reamer shaft was detached from the power tool handpiece and rotated gently by hand, uncoiling the reamer.This allowed the reamer to pass by the fracture site without catching and to be pulled back out through the entry site.
 
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Brand Name
IM REAMER, MOD. TRINKLE FITTING BIXCUT 10,0X480MM
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 Key10781504
MDR Text Key214804340
Report Number0009610622-2020-00676
Device Sequence Number1
Product Code MAY
UDI-Device Identifier04546540145376
UDI-Public04546540145376
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 01/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0225-6100
Device Catalogue Number02276100
Device Lot NumberK095B5C
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/18/2020
Date Manufacturer Received12/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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