MAUDE Adverse Event Report: STRYKER TRAUMA KIEL REDUCTION SPOON T2 FEMUR Ø9 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18060125
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
The stryker rep reported they were supporting a case where the surgeon was using the universal rod and reduction.The surgeon applied a lot of force through a hammer which caused the device to break.The spoon part of the instruments broke away from the rod, leaving it in the femoral canal.The spoon was retrieved by opening the femur at the fracture site, and the rep reported that this would of had to be carried out to reduce the fracture anyway.Slight delay, no more than 5 minutes.
Event or Problem Description
The stryker rep reported they were supporting a case where the surgeon was using the universal rod and reduction.The surgeon applied a lot of force through a hammer which caused the device to break.The spoon part of the instruments broke away from the rod, leaving it in the femoral canal.The spoon was retrieved by opening the femur at the fracture site, and the rep reported that this would of had to be carried out to reduce the fracture anyway.Slight delay, no more than 5 minutes.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the returned device is conforming to specifications and fully functional.Based on investigation this device is considered to be a concomitant device and did not contribute to the reported breakage.The case is related to the counterpart [universal rod] which is evaluated in a separate investigation report.The device inspection revealed the following: the device shows normal traces of use but is in generally good condition.The broken off tip of the counterpart [universal rod] was found to be stuck within the spoon.No further damage was verified.After removal of the stuck part the reduction spoon could be assembled and disassembled with a sample universal rod as intended.Function was given in full.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.

• Brand Name: REDUCTION SPOON T2 FEMUR Ø9 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: 8429021
• Report Number: 0009610622-2019-00110
• Device Sequence Number: 14010124
• Product Code: LXH
• UDI-Device Identifier: 04546540196040
• UDI-Public: 04546540196040
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2019

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: 18060125
• Device Lot Number: K138543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Initial Date Received by Manufacturer: 02/18/2019
• Supplement Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 03/18/2019
• Supplement Report FDA Received Date: 05/03/2019
• 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 Age: 25 YR