MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER BLADE, CANNULATED; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Catalog Number	07-40220
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed, any additional information will be reported in a supplemental report.
Event or Problem Description
The customer reported that when the screwdriver was used the internal bit which comes out had sheared off so was unable to be used.The surgeon used the 3mm new deal and managed to get compression.Delay in surgery was 45 minutes.
Additional Manufacturer Narrative
The reported event that screwdriver blade, cannulated 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 high torsional forces during screw insertion.The device inspection revealed the following: the tip of the returned inner part of the screwdriver is indeed completely broken / sheared off.The fracture surface shows the appearance of a ductile forced rupture from torsional overload.This clearly indicates that high mechanical force had been applied during screw insertion (possibly hard bone) which finally resulted in the tip breakage.Some residues / blood / corrosion are also clearly visible.Note that this device was manufactured in march 2012 and therefore been in use for several years.Note that a corrective action has already been initiated in order to further improve the current design.The user must be familiar with the instruments prior to use and should have checked to ensure that both the implant and instruments used are intact (extract from 90-01929 rev aa twin fix instruments ifu).See details below 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.
Event or Problem Description
The customer reported that when the screwdriver was used the internal bit which comes out had sheared off so was unable to be used.The surgeon used the 3mm new deal and managed to get compression.Delay in surgery was 45 minutes.

• Brand Name: SCREWDRIVER BLADE, CANNULATED
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8107641
• Report Number: 0008031020-2018-01009
• Device Sequence Number: 2261954
• Product Code: LXH
• UDI-Device Identifier: 04546540361974
• UDI-Public: 04546540361974
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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): 01/07/2019

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: 07-40220
• Device Lot Number: AC03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Initial Date Received by Manufacturer: 11/02/2018
• Supplement Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 11/27/2018
• Supplement Report FDA Received Date: 01/07/2019
• 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