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

Catalog Number	18060233
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.
Event or Problem Description
Tip of self holding screwdriver broken.
Additional Manufacturer Narrative
The evaluation revealed the broken selfholding screwdriver to be the primary product.No deviations were found during review of the manufacturing and inspection documents (dhr).The item returned was documented as faultless prior to distribution.During investigation no material, dimensional, functional, visual or manufacturing related issues were found.The reported event was confirmed; the moveable blade was found completely broken off.The breakage surface and breakage line indicated that the blade broke spontaneously in a brittle fracture most likely contrary to the plain screwdriver surface (outwards).Most likely the screwdriver broke during cleaning prior to the surgery due to inserting a cleaning tool (i.E.Towel, brush) into the trench between blade and screwdriver, so the blade material got overloaded due to bending forces.The ifu includes that all instruments shall be handled with care.Based on the investigation results the case is attributed to an inadequate usage (user related).Review of complaint history, capa databases, labelling and risk analysis did not identify any discrepancies.There are no open actions in place related to the reported event for the subject product(s).No non-conformity was identified.
Event or Problem Description
Tip of self holding screwdriver broken.

• Brand Name: SCREWDRIVER, SELF-HOLDING, LONG 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
• MDR Report Key: 7346883
• Report Number: 0009610622-2018-00079
• Device Sequence Number: 16339761
• Product Code: LXH
• UDI-Device Identifier: 04546540520425
• UDI-Public: 04546540520425
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2018

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: 18060233
• Device Lot Number: KMW351301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• Initial Date Received by Manufacturer: 03/02/2018
• Supplement Date Received by Manufacturer: 05/30/2018
• Initial Report FDA Received Date: 03/16/2018
• Supplement Report FDA Received Date: 06/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other