MAUDE Adverse Event Report: STRYKER TRAUMA KIEL CONICAL EXTRACTOR, MALE, LEFT HAND IMPLANT EXTRACTION SET 4 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-6172
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2023
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: "one item broke during the surgery, male extractor 4mm.The item snapped during use, removing a screw.The procedure was delayed by 40 min." it is unclear if any debris was left in the patient.
Event or Problem Description
As reported: "one item broke during the surgery, male extractor 4mm.The item snapped during use, removing a screw.The procedure was delayed by 40 min." it is unclear if any debris was left in the patient.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A review of the device history was not possible because the lot number was not communicated.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.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device disposition is unknown.
Additional Manufacturer Narrative
Correction - please refer to d9/h3, h6 (method, result, conclusion & clinical codes).The reported event could be confirmed, since the extractor is broken as complained.The device inspection revealed the following: a broken extractor and the affected locking screw were returned for evaluation.The visual inspection of the extractor has shown that the tip is broken off, the fragment is stuck in the recess of the received locking screw.The lateral view shows that the fracture surface is partly oblique, which indicates that high lateral stress did contribute to the breakage.The microscopic inspection of the fracture face has shown that the view is typical for a brittle overload fracture with a shear lip on one side.The shear lip also indicates that the device was exposed to high lateral forces when it broke.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.The lot in question was manufactured in september 2010 with a lot size of 22 pieces and we are not aware of any other complaint of this nature for this lot number.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 a user related issue.The failure was caused by applying too much lateral stress onto the device, which did lead to a mechanical overload.High torque may also have played a certain role as the extractor is typically used after the hexagon recess did get damaged by high loads or/and an insufficient connection, during screw insertion or extraction.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "one item broke during the surgery, male extractor 4mm.The item snapped during use, removing a screw.The procedure was delayed by 40 min." it is unclear if any debris was left in the patient.

• Brand Name: CONICAL EXTRACTOR, MALE, LEFT HAND IMPLANT EXTRACTION SET 4 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16311921
• Report Number: 0009610622-2023-00028
• Device Sequence Number: 12463239
• Product Code: LXH
• UDI-Device Identifier: 04546540510082
• UDI-Public: 04546540510082
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/26/2023

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 Model Number: 1806-6172
• Device Catalogue Number: 18066172
• Device Lot Number: K250256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2023
• Supplement Date Received by Manufacturer: 02/16/2023; 05/02/2023
• Initial Report FDA Received Date: 02/07/2023
• Supplement Report FDA Received Date: 03/16/2023; 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2010
• 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