MAUDE Adverse Event Report: STRYKER GMBH EXTRACTOR ASNIS III SCREWS Ø6.5/8.0MM LARGE AO FITTING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	702624
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Difficult to Remove (1528)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
It was reported that on (b)(6) 2020 an explantation was performed on a patient who underwent osteosynthesis with 3 aznis 6.5mm.The surgeon attempted to remove the screw with a special screwdriver, but the screwdriver wouldn't turn because the patient's bone quality was good.Two screws were removed, but one could not be removed and remained in the body.The surgeon attempted to remove the screw with another instrument; however it could not be removed.
Event or Problem Description
It was reported that on (b)(6), 2020 an explantation was performed on a patient who underwent osteosynthesis with 3 aznis 6.5mm.The surgeon attempted to remove the screw with a special screwdriver, but the screwdriver wouldn't turn because the patient's bone quality was good.Two screws were removed, but one could not be removed and remained in the body.The surgeon attempted to remove the screw with another instrument; however it could not be removed.Additional information received: - removal of implants, planned procedure because of bone healing.- during the removal procedure, two screws could be retrieved, one screw was left in patient body.Patient's bone were too hard.- one screw which was retrieved from patient's body have been shipped for inspection.The screw is broken but the information is not available if the broken part remained in patient's body.
Additional Manufacturer Narrative
Please note corrections/updates to sections b5, d4 (lot number) and h6 (device code).The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received device shows the damaged thread at the tip.The appearance of the hitting marks on the engaged device indicates that device been impacted with high force which led to jamming of instruments and subsequent damage upon hitting.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 material, 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 and provided information, the root cause was attributed to a user related issue.The damaged thread at the tip of the extractor indicates improper and rough handling of the device.If any further information is provided, the complaint report will be updated.

• Brand Name: EXTRACTOR ASNIS III SCREWS Ø6.5/8.0MM LARGE 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: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12568349
• Report Number: 0008031020-2021-00424
• Device Sequence Number: 3686842
• Product Code: LXH
• UDI-Device Identifier: 04546540112873
• UDI-Public: 04546540112873
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 12/29/2021

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: 702624
• Device Catalogue Number: 702624
• Device Lot Number: 12702Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2021
• Supplement Date Received by Manufacturer: 12/16/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 12/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2018
• 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
• Patient Sex: Unknown