MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER BLADE, T7; PLATE, FIXATION, BONE

Catalog Number	62-27015
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/05/2018
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
During surgery the tip of screwdriver break off and remain stuck in the screw interface.When the plate need to be removed later it will be difficult due to the fact that the screw interface is blocked by the broken tip of screwdriver.
Event or Problem Description
During surgery the tip of screwdriver break off and remain stuck in the screw interface.When the plate need to be removed later it will be difficult due to the fact that the screw interface is blocked by the broken tip of screwdriver.
Additional Manufacturer Narrative
Corrections to concomitant medical products and device evaluated by mfr.The reported event that screwdriver blade, t7 was alleged of 'breakage during surgery' could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by too much applied mechanical force during screw insertion.The device inspection revealed the following: the tip of the returned screwdriver blade is indeed completely broken off during screw insertion.Close up of the fracture surface revealed that some cracks are clearly evident, whereas the high applied forces led to a strain hardening / embrittlement of the material which finally resulted in the breakage (over time).The root cause of the failure was repeated powerful dynamically overload during use.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 any further information is provided, the investigation report will be updated.

• Brand Name: SCREWDRIVER BLADE, T7
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7732847
• Report Number: 0008031020-2018-00524
• Device Sequence Number: 751640
• Product Code: HRS
• UDI-Device Identifier: 04546540594150
• UDI-Public: 04546540594150
• Combination Product (Y/N): N
• PMA/510(K) Number: K141430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2018

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: 62-27015
• Device Lot Number: AF08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Initial Date Received by Manufacturer: 07/06/2018
• Supplement Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 10/15/2018
• 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