MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER BLADE T10 AO, SELF RETAINING; PLATE, FIXATION, BONE

Model Number	703880
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/29/2020
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
As reported: during the operation to remove the clavicle implant, there was a feeling of discomfort in fitting the screw and driver.When checked after the operation, the tip of the driver was damaged.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was returned for evaluation and it does not match the reported failure mode.As per the visual inspection, no visible damage could be confirmed.There were no damage marks visible on the screwdriver blade t10 ao, self retaining.As per the functional inspection, the screwdriver was tested with 2 different variax 2 t10 screws.The self-retaining function was fine, the screws could be picked up without issue.Even after trying to shake the assembly, the screws did not fall.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the above investigation the root cause of the failure is undetermined as reported issue could not be confirmed.The functional inspection was being performed and the results were ¿the self-retaining function was fine, the screws could be picked up without issue.Even after trying to shake the assembly, the screws did not fall¿.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: during the operation to remove the clavicle implant, there was a feeling of discomfort in fitting the screw and driver.When checked after the operation, the tip of the driver was damaged.

• Brand Name: SCREWDRIVER BLADE T10 AO, SELF RETAINING
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 10206531
• Report Number: 0008031020-2020-01797
• Device Sequence Number: 11331063
• Product Code: HRS
• UDI-Device Identifier: 07613327069907
• UDI-Public: 07613327069907
• Combination Product (Y/N): N
• PMA/510(K) Number: K170727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2020

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: 703880
• Device Catalogue Number: 703880
• Device Lot Number: 1000349496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Initial Date Received by Manufacturer: 06/02/2020
• Supplement Date Received by Manufacturer: 08/13/2020
• Initial Report FDA Received Date: 06/29/2020
• Supplement Report FDA Received Date: 09/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1