MAUDE Adverse Event Report: STRYKER TRAUMA KIEL U-BLADE LAG SCREW CONNECTOR GAMMA3; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1320-0330
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2020
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
As reported: "during the gamma u lag operation, when the surgeon tried to insert the u blade with the inserter according to the normal procedure, 13200330 (u lug screw connector) was damaged and broke.It was successfully removed with the pliers at the hospital.Damage due to metal fatigue was suspected.".
Event or Problem Description
As reported: "during the gamma u lag operation, when the surgeon tried to insert the u blade with the inserter according to the normal procedure, 13200330 (u lug screw connector) was damaged and broke.It was successfully removed with the pliers at the hospital.Damage due to metal fatigue was suspected.".
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.The device inspection revealed the following: the u-blade lag screw connector returned shows normal traces of use.The shaft of the u-blade lag screw connector is completely broken approx.Around the middle.Further damage was not found.The breakage surfaces of the u-blade lag screw connector show the typical appearance of a forced brittle fracture evident by smooth topography and absence of plastic deformation.The breakage happened in a slightly oblique manner indicating towards usage of this tool as a lever.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.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by improper handling during the surgery as the device was subjected to disproportionate bending forces by levering the it.If any additional information is provided, the investigation will be reassessed.

• Brand Name: U-BLADE LAG SCREW CONNECTOR GAMMA3
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 10843650
• Report Number: 0009610622-2020-00709
• Device Sequence Number: 4246122
• Product Code: HSB
• UDI-Device Identifier: 04546540377869
• UDI-Public: 04546540377869
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K032244
• 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): 01/19/2021

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: 1320-0330
• Device Catalogue Number: 13200330
• Device Lot Number: K722517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 12/31/2020
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 01/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1