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

Catalog Number	702496
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2023
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
As reported: "when the extractor for 4mm screws was used in the asnis iii removal surgery, the tip part of the extractor was broken.The fragment was removed and the surgery was completed without problem after that.".
Additional Manufacturer Narrative
Please note the corrections to d4 lot # and h6 method codes.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 device was received with a broken tip at the distal end.Both parts of the broken screwdriver were available for inspection.Microscopic views of the fracture surface show rotational deformation indicating forward application of high torsional load.The overall breakage pattern reveals a brittle fracture most likely due to a combination of high torsional and bending load.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 investigation, the root cause was attributed to being user related.The breakage shows typical signs of an overload fracture caused by high torsional and lateral loads.If any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "when the extractor for 4mm screws was used in the asnis iii removal surgery, the tip part of the extractor was broken.The fragment was removed and the surgery was completed without problem after that.".

• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17850768
• Report Number: 0008031020-2023-00346
• Device Sequence Number: 17850044
• 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): 11/23/2023

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: 702496
• Device Lot Number: 31645K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/08/2023
• Supplement Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 11/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2023
• 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