MAUDE Adverse Event Report: STRYKER GMBH EXTRACTOR ASNIS III FOR SCREWS:Ø4.0MM AO FITTING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	702496
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "during removal, the screw stopped in the middle and the tip of the extractor broke off when the surgeon kept turning it.The bone around the screw was then drilled using a crown drill and the screw was removed.In doing so, the drill tip may have hit the screw and chipped it.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the tip of the extractor is broken off as complained.The device inspection revealed the following: the visual inspection has shown that the tip of the extractor is broken off, the fragment was not returned for evaluation.The fracture face runs diagonal, which indicates high lateral forces during the breakage.The fracture face has the view of a ductile overload fracture, where first a permanent distortion of the material occurred which did finally end in the breakage of the tip.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance to the values in the material specification.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.Based on investigation, the root cause was attributed to be user related.The breakage shows typical signs of torsional and bending overload by excessive forces applied on the extractor during the extraction of the screw.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "during removal, the screw stopped in the middle and the tip of the extractor broke off when the surgeon kept turning it.The bone around the screw was then drilled using a crown drill and the screw was removed.In doing so, the drill tip may have hit the screw and chipped it.".

• Brand Name: EXTRACTOR ASNIS III FOR SCREWS:Ø4.0MM AO FITTING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13235386
• Report Number: 0008031020-2022-00008
• Device Sequence Number: 11839175
• Product Code: LXH
• UDI-Device Identifier: 04546540112415
• UDI-Public: 04546540112415
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 702496
• Device Catalogue Number: 702496
• Device Lot Number: 00257V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/15/2021
• Supplement Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 01/12/2022
• Supplement Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown