MAUDE Adverse Event Report: STRYKER TRAUMA KIEL ONE STEP CONICAL REAMER GAMMA3® Ø15.5X350 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1320-0011
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/06/2020
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
Primary procedure, left femur.It was reported that the 15 +5 opening reamer snapped at the taper for chucking into the drill.The device had not yet come in contact with patient bone, but was in the soft tissue.The location of the break was outside of the patient.The device was removed, patient visually inspected, and device reassembled at back table to ensure no pieces remained in the patient.A second instrument was obtained to complete the procedure successfully with a delay of less than one minute.
Event or Problem Description
Primary procedure, left femur.It was reported that the 15 +5 opening reamer snapped at the taper for chucking into the drill.The device had not yet come in contact with patient bone, but was in the soft tissue.The location of the break was outside of the patient.The device was removed, patient visually inspected, and device reassembled at back table to ensure no pieces remained in the patient.A second instrument was obtained to complete the procedure successfully with a delay of less than one minute.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: a one step conical reamer gamma3® ø15.5x350 mm was received for evaluation.The device shows signs of an intense and frequent use; the tri-flat adapter is completely broken off.The breakage surfaces show a smooth structure.Breakage line and typography of the fracture surfaces indicating a forced fracture due to torsional and bending overload.Functional inspection: due to the nature of the returned device, a functional inspection was not possible.Dimensional inspection: due to the nature of the returned device, a dimensional inspection was not possible.However, during manufacturing, functionality test and dimensional inspection were done according to specifications.During the inspection, all devices met the specifications.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.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by rough handling.

• Brand Name: ONE STEP CONICAL REAMER GAMMA3® Ø15.5X350 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• MDR Report Key: 9789626
• Report Number: 0009610622-2020-00092
• Device Sequence Number: 11425604
• Product Code: LXH
• UDI-Device Identifier: 04546540388940
• UDI-Public: 04546540388940
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2020

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: 1320-0011
• Device Catalogue Number: 13200011
• Device Lot Number: K773581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Initial Date Received by Manufacturer: 02/06/2020
• Supplement Date Received by Manufacturer: 05/06/2020
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 06/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR