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

Catalog Number	02273000S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Facility stated bixcut reamer tip broke off from shaft.Reamer head was left in patient femur.Ball tip wire was not used.
Event or Problem Description
Facility stated bixcut reamer tip broke off from shaft.Reamer head was left in patient femur.Ball tip wire was not used.
Additional Manufacturer Narrative
The reported event that reamer shaft, mod.Trinkle bixcut ø8.0x448 mm was alleged of issue (instruments - reamer - broken) could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, based on complaint history and risk management file some of the possible causes of this failure are mechanical overstressing, ao joint damaged, handling failure etc.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.A review of the labeling did not indicate any abnormalities.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: REAMER SHAFT, MOD.TRINKLE 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
• MDR Report Key: 7671500
• Report Number: 0009610622-2018-00291
• Device Sequence Number: 2580932
• Product Code: LXH
• UDI-Device Identifier: 04546540430199
• UDI-Public: 04546540430199
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2018

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: 02/28/2023
• Device Catalogue Number: 02273000S
• Device Lot Number: K06B029
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/12/2018
• Supplement Date Received by Manufacturer: 09/27/2018
• Initial Report FDA Received Date: 07/09/2018
• Supplement Report FDA Received Date: 10/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 102