MAUDE Adverse Event Report: STRYKER TRAUMA KIEL IM REAMER, AO FITTING BIXCUT 11,0X480 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	0225-6110
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	06/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
Sales rep reported that: "a reamer broke (head) in the patient after use." the head of the reamer seems to have stayed in the patient.
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: appearance of the damage patterns of the returned reamer indicate that it broke under high torsional load whilst it was processed in clockwise direction.According to information received the reamer was used without a guide wire which is considered ¿failure to follow instructions¿.A review of the labeling did not indicate any abnormalities.The ifu instructs: ¿always perform intramedullary reaming over a k-wire to prevent the reamer from drifting uncontrollably.¿.The op-technique ¿gamma3 hip fracture nailing system operative technique¿ instructs: ¿alternative 1: reaming the medullary canal a 3mm ball-tipped guide wire is recommended as a reamer guide.Pass the guide wire through the cannulated curved awl, or other opening device, into the shaft of the femur as shown, using the guide wire handle.The ball-tipped guide wire must be used to prevent over insertion of the reamer.¿.If a guide wire would have been used, such breakage most likely would not have occurred.In case of a sheared off reamer head over a guide wire the ball tip at the end of the guide wire would have stopped and retrieved the reamer head.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 material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by torsional overload and performing intramedullary reaming without using a guide wire (to prevent the reamer from drifting uncontrollably), which most likely has led to the reamer head breakage.If any further information is provided, the complaint report will be updated.
Event or Problem Description
Sales rep reported that : "a reamer broke (head) in the patient after use." the head of the reamer seems to have stayed in the patient.
Event or Problem Description
Sales rep reported that : "a reamer broke (head) in the patient after use." the head of the reamer seems to have stayed in the patient.
Additional Manufacturer Narrative
The conclusion was revised as follows, based on additional information received: the reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: appearance of the damage patterns of the returned reamer indicate that it broke under high torsional load whilst it was processed in clockwise direction.According to information received the user had noticed an excess torsion of the ribbon at the head / shaft junction before using this reamer.A review of the labeling did not indicate any abnormalities.The ifu instructs: ¿the stryker "instructions for cleaning, sterilization, inspection and maintenance" [.] help to determine whether an instrument is in good condition or must be replaced due to excessive wear or obvious defects.Before the surgical procedure, ensure that all components prepared for the procedure function correctly with each other.Always perform intramedullary reaming over a k-wire to prevent the reamer from drifting uncontrollably.The op-technique ¿gamma3 hip fracture nailing system operative technique¿ instructs: ¿alternative 1: reaming the medullary canal a 3mm ball-tipped guide wire is recommended as a reamer guide.Pass the guide wire through the cannulated curved awl, or other opening device, into the shaft of the femur [.] using the guide wire handle.The ball-tipped guide wire must be used to prevent over insertion of 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.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by torsional overload which most likely has led to the reamer head breakage.The user had noticed an excess torsion of the ribbon at the head / shaft junction before using this reamer and ifu states to determine before the surgical procedure whether an instrument is in good condition or must be replaced due to excessive wear or obvious defects and ensure that all components prepared for the procedure function correctly with each other.If any further information is provided, the complaint report will be updated.

• Brand Name: IM REAMER, AO FITTING BIXCUT 11,0X480 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 10279819
• Report Number: 0009610622-2020-00322
• Device Sequence Number: 1045324
• Product Code: LXH
• UDI-Device Identifier: 04546540145390
• UDI-Public: 04546540145390
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/11/2020

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: 0225-6110
• Device Catalogue Number: 02256110
• Device Lot Number: K042849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Initial Date Received by Manufacturer: 06/18/2020
• Supplement Date Received by Manufacturer: 09/10/2020; 10/15/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 10/06/2020; 11/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1