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

Model Number	1320-0310
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/22/2020
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: "a patient who had injured in a fall accident at the end of last year (date unknown), operated with gamma nails and u lags (left side) and performed removal surgery.Removal procedure was performed in order.But after removing the set screw, when the u lag screwdriver and the u lag were attached, and turned it counterclockwise, the tip of the claw broke and it could not be removed.After that, a normal lug driver was also connected, but the claws of the normal lag driver also broke, making it difficult to remove.Since it took time and the risk increased, the wound was closed without removing implant.".
Event or Problem Description
As reported: "a patient who had injured in a fall accident at the end of last year (date unknown), operated with gamma nails and u lags (left side) and performed removal surgery.Removal procedure was performed in order.But after removing the set screw, when the u lag screwdriver and the u lag were attached, and turned it counterclockwise, the tip of the claw broke and it could not be removed.After that, a normal lug driver was also connected, but the claws of the normal lag driver also broke, making it difficult to remove.Since it took time and the risk increased, the wound was closed without removing implant.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received u-blade lag screwdriver and lag screwdriver were found to be damaged around the distal portion.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.The u-blade lag screwdriver was manufactured in 2008 and lag screwdriver in 2014, so it can be said that these have performed their function in the previous surgeries as intended without any reported failure.Since these have been long in use, thus a normal weakened structural integrity due to repeated reprocessing cycles is considered possible.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.The instructions for use instructs user that: ¿changes in mechanical, physical or chemical characteristics introduced under conditions of repeated use, cleaning and re-sterilization may compromise the integrity of the design and/or materials leading to diminished safety, performance and/or compliance with relevant specifications.Do not hit instruments unless they are specifically intended for impaction.Always treat the instrument carefully to avoid surface damage or alterations to the geometry.The stryker "instructions for cleaning, sterilization, inspection and maintenance" help to determine whether an instrument is in good condition or must be replaced due to excessive wear or obvious defects.¿ based on investigation, the root cause was attributed to a normal wear related issue.The u-blade lag screwdriver was manufactured in 2008, so it can be said that it has performed its function in the previous surgeries as intended without any reported failure.Since it has been long in use, thus a normal weakened structural integrity due to repeated reprocessing cycles is considered possible.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; GM D-24232
• MDR Report Key: 10848196
• Report Number: 0009610622-2020-00710
• Device Sequence Number: 4169126
• 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): 02/09/2021

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: 1320-0310
• Device Catalogue Number: 13200310
• Device Lot Number: K730830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 02/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 28 YR