MAUDE Adverse Event Report: STRYKER GMBH IM REAMER, AO FITTING BIXCUT Ø9,0X480 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	02256090
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
It was reported that ''most of the reamers, even after all the measures put in place to clean them, such as ultrasonic cleaning, swabbing, and connecting them to a washer-disinfector to wash the cavities, still have traces on the inside that are sometimes difficult to identify, such as blood or red metal.These reamers were removed and replaced with new ones.Despite the vigilance that has been put in place, it still happens that a dm is delivered to the or with insufficient cleaning, which causes the dirt to be diluted when the steam comes into contact with it, so that the tray cannot be used - dirty reamers detected when the tray is opened in the or).After all these incidents and the number of reamers removed because of non-compliant cleaning, and our commitment to providing a clean and functional dmx, our request is that the supplier/manufacturer take the position of making these dmx single use.'' for (b)(6) 2024: we had to order 51 reamers, all references combined, to replace the non-compliant ones.''.
Additional Manufacturer Narrative
Correction - please refer to h6 (method & results code).The reported event could be confirmed during the investigation.The affected device has not been returned, however, photos were received.The reported event could be confirmed, as a substance, possibly dried blood and/or corrosion, is visible inside the device's cavity.Despite the requests made, the products used and the parameters chosen during cleaning and sterilization have not been communicated by the user.Without this information and without the return of the devices for proper inspection, no detailed investigation was possible.Therefore, the exact root cause of the reported event could not be determined.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that "''most of the reamers, even after all the measures put in place to clean them, such as ultrasonic cleaning, swabbing, and connecting them to a washer-disinfector to wash the cavities, still have traces on the inside that are sometimes difficult to identify, such as blood or red metal.These reamers were removed and replaced with new ones.Despite the vigilance that has been put in place, it still happens that a dm is delivered to the or with insufficient cleaning, which causes the dirt to be diluted when the steam comes into contact with it, so that the tray cannot be used - dirty reamers detected when the tray is opened in the or).After all these incidents and the number of reamers removed because of non-compliant cleaning, and our commitment to providing a clean and functional dmx, our request is that the supplier/manufacturer take the position of making these dmx single use.'' for 2024: we had to order 51 reamers, all references combined, to replace the non-compliant ones.''.
Additional Manufacturer Narrative
Correction - please refer to d9 product returned, h6 (method & results code).The reported event could be confirmed during the investigation.The inspection revealed the following: the identification of the returned device could be confirmed based on the catalog number and the lot number marked.The cavity of the device was inspected with an endoscope.Small particles were found inside the device, most probably metal or plastic, probably remaining after cleaning and sterilization or having occurred during transportation.It was not possible to determine the exact nature of these particles.Photos showing a substance inside the cavity of some reamers, possibly dried blood and/or corrosion, were received.However, due to the lack of information, the references of the device(s) in question could not be identified.Given the nature of the particles could not be determined, it was not possible to determine the exact root cause of the event.Nonetheless, any design or manufacturing related issue could be ruled out.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that "''most of the reamers, even after all the measures put in place to clean them, such as ultrasonic cleaning, swabbing, and connecting them to a washer-disinfector to wash the cavities, still have traces on the inside that are sometimes difficult to identify, such as blood or red metal.These reamers were removed and replaced with new ones.Despite the vigilance that has been put in place, it still happens that a dm is delivered to the or with insufficient cleaning, which causes the dirt to be diluted when the steam comes into contact with it, so that the tray cannot be used - dirty reamers detected when the tray is opened in the or).After all these incidents and the number of reamers removed because of non-compliant cleaning, and our commitment to providing a clean and functional dmx, our request is that the supplier/manufacturer take the position of making these dmx single use.'' for 2024: we had to order 51 reamers, all references combined, to replace the non-compliant ones.''.

• Brand Name: IM REAMER, AO FITTING BIXCUT Ø9,0X480 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21355478
• Report Number: 0008031020-2025-00272
• Device Sequence Number: 8959370
• Product Code: LXH
• UDI-Device Identifier: 04546540145352
• UDI-Public: (01)04546540145352(10)K1A2A19
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/10/2025

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 Catalogue Number: 02256090
• Device Lot Number: K1A2A19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 04/01/2025; 08/13/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 04/28/2025; 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown