MAUDE Adverse Event Report: STRYKER GMBH CONICAL EXTRACTOR, MALE, LEFT HAND IMPLANT EXTRACTION SET 2.5 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18066170
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2023
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: "the head of the end cap slipped during removal, causing removal difficulty.The end cap was locked tightly and the tip of the screwdriver was deformed.The reverse threaded screwdriver of the removal instrument was also broken.Other instruments used were also damaged.Finally the end cap and other implants were removed from the patient.".
Additional Manufacturer Narrative
Please note corrections to section d4 (catalog#, lot#, gtin and product description).The reported event could be confirmed, since the conical extractor is broken as reported.The device inspection revealed the following: the visual inspection of the conical extractor has shown that the tip is broken off, the fragment was not returned for evaluation.The fracture surface runs obliquely, which is an indication of high lateral stress.The microscopic evaluation of the fracture face shows 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.Based on that it can be concluded that a combination of high torsional force and lateral stress did lead to a mechanical overload and finally the breakage.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 a user related issue.The event was ultimately caused by using a incorrect screwdriver for the removal of a by strongly tightened end cap that was implanted for more than one year.The initially used spreading recon lag screwdriver bit is cannulated and slotted at the hexagon and no designed to take such high forces.The slot in the hexagon had the effect that the tip was pushed together and as a result the force was no longer distributed as intended over the surfaces of the hexagon, which resulted in damage to the screwdriver and certainly also to the end cap recess.As stated in the t2 alpha femur antegrade operative technique is the set screw or end cap removed with the solid screwdriver bit, long, which is catalog # 2351-0110.After the end cap recess was damaged a removal with the standard screwdriver was not possible anymore.Therefore a end cap removal attempt with the compression screwdriver was made, but the hexagon of this screwdriver is also not designed for end cap removal, the tip smaller and much softer and get therefore easily damaged when excessive forces are applied.The conical extractor, which was used because of the damaged end cap recess, did break as too much torsional and lateral force was applied onto the device.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "the head of the end cap slipped during removal, causing removal difficulty.The end cap was locked tightly and the tip of the screwdriver was deformed.The reverse threaded screwdriver of the removal instrument was also broken.Other instruments used were also damaged.Finally the end cap and other implants were removed from the patient.".

• Brand Name: CONICAL EXTRACTOR, MALE, LEFT HAND IMPLANT EXTRACTION SET 2.5 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• 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: 18425680
• Report Number: 0009610622-2024-00003
• Device Sequence Number: 7730947
• Product Code: LXH
• UDI-Device Identifier: 04546540510068
• UDI-Public: 04546540510068
• 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): 03/12/2024

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: 18066170
• Device Lot Number: KSS1940H8
• 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: 12/08/2023
• Supplement Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2019
• 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 Age: 57 YR
• Patient Sex: Male
• Patient Weight: 90 KG