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

Catalog Number	02256080
Medical Device Problem Codes	Break (1069); Fracture (1260); Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported: "reamer performance/quality fault (stryker) during bone drilling, the reamer shaft broke while the motor was applying rotation for reaming.When the reamer was removed, the 1st steel twist deformed, making it very difficult to remove the device.This had an impact on the operating time, which was lengthened by the laborious removal of the device.Immediately after removal of the reamer, the operating team took an x-ray to check that there was no debris/foreign bodies in the patient's bone tissue.The x-ray confirmed that there was no debris and that the operation could continue.Current state of the patient: consequences: significant loss of operating time, estimated at 20 minutes.Critical incident for the patient, who fortunately suffered no impact.Actions taken in the care facility to manage the patient: painstaking removal of device of the device.X-ray confirmed absence of debris and possibility of continuing the operation.Change of the medical device with larger reamer to continue the operation.There was also a significant economic loss due to the loss of the re-sterilisable device.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned, and matches the alleged failure.The received im reamer, ao fitting bixcut was visually inspected, where we can see that the outer coil is completely unwounded leading to an increase in the diameter at the distal end near the reaming flutes which made it hard to remove the shaft from the bone which caused the application of high torqueing and lateral stresses, causing the shaft breakage in brittle manner and extensive damage throughout the reamer.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.The ifu states that :- ¿ never operate an intramedullary reamer in a counter-clockwise direction.Doing so causes the reamer shaft spiral to open and may lead to additional trauma.¿ [original statement(s)].No indications of material, manufacturing or design related problems were found during the investigation.Based on the investigation, the root cause was attributed to user related, as the shaft spiral is unwounded which indicates that the reamer was used in counter-clockwise direction and the broken shaft shows that the application of high torqueing and lateral stresses.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The customer reported: "reamer performance/quality fault (stryker) during bone drilling, the reamer shaft broke while the motor was applying rotation for reaming.When the reamer was removed, the 1st steel twist deformed, making it very difficult to remove the device.This had an impact on the operating time, which was lengthened by the laborious removal of the device.Immediately after removal of the reamer, the operating team took an x-ray to check that there was no debris/foreign bodies in the patient's bone tissue.The x-ray confirmed that there was no debris and that the operation could continue.Current state of the patient: consequences: significant loss of operating time, estimated at 20 minutes.Critical incident for the patient, who fortunately suffered no impact.Actions taken in the care facility to manage the patient: painstaking removal of device of the device.X-ray confirmed absence of debris and possibility of continuing the operation.Change of the medical device with larger reamer to continue the operation.There was also a significant economic loss due to the loss of the re-sterilisable device.".

• Brand Name: IM REAMER, AO FITTING BIXCUT Ø8,0X480 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17847995
• Report Number: 0009610622-2023-00339
• Device Sequence Number: 7381890
• 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: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2023

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: 02256080
• Device Lot Number: K0C0290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/04/2023
• Supplement Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 09/29/2023
• Supplement Report FDA Received Date: 12/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2022
• 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