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

Model Number	0225-6080
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/04/2020
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
Sales rep reported that : "following an operation on a young patient with a thick cortex, the reamers broke." the device was changed to proceed with the procedure with a delay of 5min.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure.The returned im reamer shows normal traces of use.The flexible shaft of the reamer was found to be broken from the proximal end where it joins with the adapter.The breakage surface shows the typical characteristics of a brittle fracture due to torsional overload.The flutes of the reamer head were also blunt, worn out and abraded.Dimensional inspection of the device revealed all the critical dimensions to be within specification.The adapter tube diameter was observed 6.981mm against the required range of 6.98mm - 7.00mm.A tensile test of the material in close proximity to the breakage area revealed tensile to be greater than the required minimum.An average value of 908 mpa (includes variation in testing and conversion from hardness number to tensile strength) was observed against the required minimum of 650 mpa.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.Additionally, it should be noted; the returned device has been refurbished by an external source which is indicated by the engraving on the adapter, thus stryker is not responsible for the device.Based on the investigation it was found that although there was failure confirmation, there was already a refurbishment done to the reamer as indicated by the engraving on the adapter.This marking is not made by stryker at any point of time.Instruments which are refurbished by third parties/external sources and then returned to the customers are not regarded to have been put on the market by stryker.After any sort of rework done externally, they become products of a third party.There are no warranty claims against stryker for third-party products.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
Sales rep reported that : "following an operation on a young patient with a thick cortex, the reamers broke." the device was changed to proceed with the procedure with a delay of 5min.

• 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; DE D-24232
• MDR Report Key: 9661571
• Report Number: 0009610622-2020-00041
• Device Sequence Number: 379530
• Product Code: LXH
• UDI-Device Identifier: 04546540145338
• UDI-Public: 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: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2020

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: K0C08F1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 04/01/2020
• Initial Report FDA Received Date: 02/03/2020
• Supplement Report FDA Received Date: 04/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1