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 Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2020
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
The customer reported to (b)(4) that : "we noticed a clear breakage of one of your screwdrivers.Ref : ref 1806-0203/1, lot kmw351702 (for the screwdriver part) and ref 1806-0203/2, lot kmw350701 (for the part that fits on the screwdriver).".
Event or Problem Description
The customer reported to frederic vauges (sr) that : "we noticed a clear breakage of one of your screwdrivers.Ref : ref 1806-0203/1, lot kmw351702 (for the screwdriver part) and ref 1806-0203/2, lot kmw350701 (for the part that fits on the screwdriver).".
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 screwdriver with the self-holding feature is broken and shows normal traces of use.The breakage surface shows the typical characteristics of a brittle fracture.Area just above the breaking point shows material deformation and breakage surface also shows a curved scuff mark, both of which indicates high rotational and bending load.To prevent the bending, the device is also laser-marked with the printing ¿do not lever¿.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A process change was performed; the wch coating was removed to prevent breakages of the moveable blade.The returned screwdriver manufacturing date post-dates the process change.Furthermore it is recommended that the screwdriver shall be treated with an appropriate instrument spray after every usage.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 user related issue.The failure was caused due to inadequate handling by the user i.E.Breakage under overloading of screwdriver.The appearance of the breakage surface indicates a (forced) brittle breakage of the screw driver due to bending and rotational forces overload, in spite of the clear warning laser marked on the device itself that ¿do not lever¿.If any further information is provided, the investigation report will be reassessed.

• 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: 11189780
• Report Number: 0009610622-2021-00238
• Device Sequence Number: 17027440
• Product Code: LXH
• UDI-Device Identifier: 04546540520418
• UDI-Public: 04546540520418
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2021

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: KMW350701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Initial Date Received by Manufacturer: 12/23/2020
• Supplement Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 01/18/2021
• Supplement Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1