MAUDE Adverse Event Report: STRYKER TRAUMA KIEL REAMER SHAFT, AO FITTING BIXCUT Ø8,0X448 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	0226-3000S
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
The customer reported to ansm under ref number r(b)(4) the following incident: "date occurred:(b)(6) 2021.Incident description: presence of a piece of plastic at the end where the boring olives should be positioned.Risk of leaving plastic in the femoral diaphysis during reaming.The offending reamer was not used on the patient: another reamer was opened.The incriminated reamer is available for expertise upon request from the laboratory to the material safety officer.".
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
The customer reported to (b)(6) under (b)(4) the following incident: "date occurred:(b)(6) 2021.Incident description: presence of a piece of plastic at the end where the boring olives should be positioned.Risk of leaving plastic in the femoral diaphysis during reaming.The offending reamer was not used on the patient: another reamer was opened.The incriminated reamer is available for expertise upon request from the laboratory to the material safety officer.".
Additional Manufacturer Narrative
Please note corrections to section h6 (device code).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 received im reamer shaft revealed a disfigured and deformed grommet at the distal end.The damage looks to have occurred during the insertion of the grommet.Overall, the shaft looks relatively damage free.It was also observed that the grommet was undamaged around the clamping points.All of this confirms that the device couldn't be used at all in the surgery and hence it is an out-of-box failure.A review of the labeling did not indicate any abnormalities.Protruded grommets are known from previous complaints; a nc was initiated in october 2012 and actions were implemented in november 2012.The insertion tool was changed, and the process was updated.The returned reamer shaft was manufactured in january 2021, after the actions were implemented.In the current case, it could be identified that the grommet was not inserted correctly during manufacturing.Therefore, a new nc has been initiated to address the issue.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The customer reported to ansm under ref number: (b)(4) the following incident: "date occurred: on (b)(6) 2021.Incident description: presence of a piece of plastic at the end where the boring olives should be positioned.Risk of leaving plastic in the femoral diaphysis during reaming.The offending reamer was not used on the patient: another reamer was opened.The incriminated reamer is available for expertise upon request from the laboratory to the material safety officer.".

• Brand Name: REAMER SHAFT, AO FITTING BIXCUT Ø8,0X448 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13388720
• Report Number: 0009610622-2022-00034
• Device Sequence Number: 11995715
• Product Code: LXH
• UDI-Device Identifier: 07613153281641
• UDI-Public: 07613153281641
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 04/25/2022

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 Expiration Date: 12/31/2025
• Device Model Number: 0226-3000S
• Device Catalogue Number: 02263000S
• Device Lot Number: K026492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2022
• Supplement Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 01/28/2022
• Supplement Report FDA Received Date: 04/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown