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

Model Number	1320-0310
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when removing the gamma 3u lag screw, due to a postoperative refracture, a u-lag screwdriver was attached to the posterior end of the lag screw and an attempt was made to remove the screw, but the screwdriver could not be removed.The tips of two screwdrivers were damaged as a result of excessive force.All debris was removed from the surgical area.Although re-fixation with t2alpha was the first choice after extraction, it was switched to another company's femoral plate as the gamma3 nail was unable to be extracted.It was also reported that there was a 180 minute surgical delay.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that when removing the gamma 3u lag screw, due to a postoperative refracture, a u-lag screwdriver was attached to the posterior end of the lag screw and an attempt was made to remove the screw, but the screwdriver could not be removed.The tips of two screwdrivers were damaged as a result of excessive force.All debris was removed from the surgical area.Although re-fixation with t2alpha was the first choice after extraction, it was switched to another company's femoral plate as the gamma3 nail was unable to be extracted.It was also reported that there was a 180 minute surgical delay.
Additional Manufacturer Narrative
Please note the correction to h6 device code.The reported event could be confirmed.The device inspection revealed the following: the identification of the returned device was confirmed based on the catalog # and the lot# marked.Both tips of the screwdriver (u-blade and screwdriver) are deformed, especially the threaded tip of the screwdriver.Wear marks, possibly resulting from hammering could be observed on the screwdriver.During a functional test, both parts could still be assembled, however due to the deformation of the screwdriver, the parts assembling and disassembling of the parts was only possible with much effort.The visible deformation of both ends indicates that the functionality of the u-blade lag screwdriver cannot be given anymore.No other form of inspection was performed.However, during manufacturing a dimensional inspection was done according to specifications.During the inspection, all devices met the specifications.Based on the investigation, the root cause was attributed to an user related issue.It is possible that the screwdriver was not fully aligned with the screw when the explantation was performed, thus excessive torsional and possible pending loads were applied to the instrument, leading to its deformation.Hammering, performed in previous surgeries or during the surgery of the reported event should be avoided and may have influenced the deformation of the device.As a reminder, the operative technique clearly states: " the handle must be perpendicular to the target device, when the u-blade lag screw is in the final position.Check that soft tissue does not obstruct secure engagement of the u-blade lag screwdriver, otherwise the u-blade lag screw or screwdriver may be damaged and extraction will be much more difficult.".The instructions for use clearly state: " during the procedure, repeatedly check that the connections between the instruments or between implants and instruments required for the precise positioning and fixing are secure.Do not hit instruments unless they are specifically intended for impaction.Never hit targeting devices or elastosil handles other than those with an integrated strike plate! ".It has to be taken into account that possible bone ingrowth may have happened around the screw head, which could explain the difficulty to explant the screw and the excessive force needed, leading to the deformation of the device.However, no information was received regarding bone ingrowth, therefore nothing can be stated on that matter.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.If more information is provided, the case will be reassessed.

• 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; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15577342
• Report Number: 0009610622-2022-00460
• Device Sequence Number: 20667035
• Product Code: HSB
• UDI-Device Identifier: 04546540377845
• UDI-Public: 04546540377845
• 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): 11/16/2022

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: 1320-0310
• Device Catalogue Number: 13200310
• Device Lot Number: K0D81E3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2022
• Supplement Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 11/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male