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

Catalog Number	13200310
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/10/2019
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 inserting the distal pins of the u-blade lag screwdriver broke apart.New u-blade set was opened to complete the procedure successfully.".
Event or Problem Description
As reported: "during inserting the distal pins of the u-blade lag screwdriver broke apart.New u-blade set was opened to complete the procedure successfully.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure.The device inspection revealed the following: the device received shows traces of intense and frequent usage.The pegs at the tip of the driver are completely broken off.The broken pegs are not available for evaluation.The remnant pegs show typical signs of a forced, ductile breakage due to overload with evident material displacement.This indicates intense usage of the lag screwdriver with high torque application.Based on the investigation the root cause of the reported event was not related to a deficiency of the device but was rather linked to a user related factor.The failure has occurred due to overloading of the screwdriver during use.It cannot be excluded that this breakage is also affected in combination by stresses developed during previous surgeries and multiple sterilization cycles.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 manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.If any further information is provided, the complaint report will be updated.

• Brand Name: U-BLADE LAG SCREWDRIVER 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
• MDR Report Key: 9050523
• Report Number: 0009610622-2019-00681
• Device Sequence Number: 2550139
• Product Code: HSB
• UDI-Device Identifier: 04546540377845
• UDI-Public: 04546540377845
• Combination Product (Y/N): N
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2019

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: 13200310
• Device Lot Number: K0DCB96
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Initial Date Received by Manufacturer: 08/19/2019
• Supplement Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 09/13/2019
• Supplement Report FDA Received Date: 10/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1