MAUDE Adverse Event Report: STRYKER TRAUMA KIEL IM REAMER, AO FITTING BIXCUT Ø8,0X480 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	0225-6080
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed, any additional information will be reported in a supplemental report.
Event or Problem Description
The pharmacist at the clinic, reported the following event to the sales rep : "rupture of the guide wire ref (b)(4) into the reamer shaft diam 8.The guide could not slide and finally fractured into the shaft.Is it a wear fail doctor indicated that the event occured during a tibial nailing.There was a delay in the procedure, increase of the infection risk and peroperative fracture.It was necessary to change the guide and to reduce the fracture again.
Additional Manufacturer Narrative
The reported event that im reamer, ao fitting bixcut ø8,0x480 mm was alleged of k-378 (no deviation found) could not be confirmed, however, the returned device could be confirmed of issue ( instruments - reamer ¿ broken).Visual inspection: im reamer, ao fitting bixcut ø8,0x480 mm was found to be broken near the tip.Im reamer, ao fitting bixcut ø8,0x480 mm broken surface visually inspected under microscope.Small signs of usages (dents) are visible on the cutting edges, but the reamers are still sharp.Most likely the reamer broke off within the marrow channel during reaming.In case a too big diameter is used it is possible that the reamer cutting edges got stuck in the corticalis due to undue bone material removal.In case the reamer will be operated in jammed mode it is possible that the spiral shaft windings get overloaded by too high torsional forces applied by the power tool.Furthermore, as the guide wire tip have scratches and bend (increases jamming)(confirmed by event description that the guide could not slide), it is possible that the reamer head got stuck at the point of the deformed guide wire area.Thus, reamer got overloaded and finally the head broke off.Functional inspection: functional test was performed with a sample guide wire (ø 3 mm).It was not possible to move the guide wire through the both segments of broken reamer.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.As the reamer had been in use for more than 2 years (manufactured in february 2016), it can be safely said that the device had fulfilled its tasks in former surgeries as intended.Instrument damage is usually found during functional check (required per ifu).In case of any deviation it is realized prior to use.Considering that was confirmed by pre-operative check it was concluded that the event was mainly based in the intra-operative procedure.Based on investigation, the root cause was attributed to a user related issue.The failure is caused due to failure to follow the operative technique/instruction for use properly.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The pharmacist at the clinic, reported the following event to the sales rep : "rupture of the guide wire ref (b)(4) into the reamer shaft diam 8.The guide could not slide and finally fractured into the shaft.Is it a wear fail doctor indicated that the event occured during a tibial nailing.There was a delay in the procedure, increase of the infection risk and peroperative fracture.It was necessary to change the guide and to reduce the fracture again.

• Brand Name: IM REAMER, AO FITTING BIXCUT Ø8,0X480 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 7481263
• Report Number: 0008031020-2018-00347
• Device Sequence Number: 10811471
• Product Code: LXH
• UDI-Device Identifier: 04546540145338
• UDI-Public: (01)04546540145338
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2018

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
• Operator of Device: Health Professional
• Device Model Number: 0225-6080
• Device Catalogue Number: 02256080
• Device Lot Number: K098843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2018
• Initial Date Received by Manufacturer: 04/23/2018
• Supplement Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 05/02/2018
• Supplement Report FDA Received Date: 11/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other