MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER T20; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	703539
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/22/2019
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.Device disposition is unknown.
Event or Problem Description
It was reported that during surgical procedure, the tip of the screwdriver was observed to be disfigured/ deformed prior to use.Another device was used to complete the procedure with no surgical delay.Rep reported that x-rays, medical records, and further information will not be released by the hospital or surgeon.Upon review of received damaged device the screwdriver was confirmed to be broken, the tip appears to be missing.
Event or Problem Description
It was reported that during surgical procedure, the tip of the screwdriver was observed to be disfigured/ deformed prior to use.Another device was used to complete the procedure with no surgical delay.Rep reported that x-rays, medical records, and further information will not be released by the hospital or surgeon.Upon review of received damaged device the screwdriver was confirmed to be broken, the tip appears to be missing.
Additional Manufacturer Narrative
The reported event could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by applying too much torque on the device, as well as the natural wear of it, since it has been used since 2011.The device inspection revealed the following: the product was not returned but a picture was provided.As the event description states, the tip of the device is indeed deformed.The grooves at the tip of the screwdriver are not straight, but are instead twisted in the unscrewing direction.This proves that the plastic deformation that this screw went through happened when the device was used to unscrew a screw.It is not known if the screw in question was freshly implanted or if it was during the extraction of an osseointegrated screw.However, the obvious root cause for this device's deformation and then breakage is an overtightening/ application of too much torque during the unscrewing phase.As a reminder, the ifu clearly states: ¿ 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 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 the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: SCREWDRIVER T20
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8434673
• Report Number: 0008031020-2019-00279
• Device Sequence Number: 13899621
• Product Code: LXH
• UDI-Device Identifier: 04546540693778
• UDI-Public: 04546540693778
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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): 05/02/2019

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: 703539
• Device Lot Number: K153305
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/22/2019
• Supplement Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 03/19/2019
• Supplement Report FDA Received Date: 05/02/2019
• 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