MAUDE Adverse Event Report: STRYKER TRAUMA KIEL SCREWDRIVER, SELF-HOLDING, EXTRA SHORT SCREWDRIVER, SELF-HOLDING 3.5 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-0203
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2021
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: "at the time of the proximal side stop, even though the surgeon drilled with the target device, it felt like it was just barely in, and the screw did not go in beyond the sleeve.Then the surgeon removed the target device and attached the screw to the self-holding drive, driver's tip was chipped because it lost the torque of the nail and bone.Thereafter, the surgeon was able to reattach it to the long self-holding driver again and the operation was completed without problem.".
Additional Manufacturer Narrative
Correction: please refer to d4 lot number , h6 device code.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 returned screwdriver with self-holding feature shows normal traces of use.The moveable blade was found completely broken off at the level of the end of the slot.The black wch coating is only visible on the screwdriver thread.Therefore, the screwdriver is a new design version.The breakage surface shows the typical structure of a brittle breakage; plastic deformation, especially along the rim of the breakage surface, was not found.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.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.Please refer to the device label to identify single or multiple use and/or cleaning and re-sterilization release.Always treat the instrument carefully to avoid surface damage or alterations to the geometry.The design of the instrument must not be modified in any way.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 device was manufactured in 2009, 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.
Event or Problem Description
As reported: "at the time of the proximal side stop, even though the surgeon drilled with the target device, it felt like it was just barely in, and the screw did not go in beyond the sleeve.Then the surgeon removed the target device and attached the screw to the self-holding drive, driver's tip was chipped because it lost the torque of the nail and bone.Thereafter, the surgeon was able to reattach it to the long self-holding driver again and the operation was completed without problem.".

• Brand Name: SCREWDRIVER, SELF-HOLDING, EXTRA SHORT SCREWDRIVER, SELF-HOLDING 3.5 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 11499122
• Report Number: 0009610622-2021-00422
• Device Sequence Number: 19797899
• Product Code: LXH
• UDI-Device Identifier: 04546540520418
• UDI-Public: 04546540520418
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/23/2021

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: 1806-0203
• Device Catalogue Number: 18060203
• Device Lot Number: KMW350704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1