MAUDE Adverse Event Report: STRYKER GMBH 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 Code	Insufficient Information (4580)
Date of Event	03/10/2023
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 by the sales rep, "surgeon encountered difficulties in the removal of a t2 tibia nail.It proved impossible to remove the obturator plug and, by extension, the nail despite the use of stryker extraction kits.A left-handed screwdriver, reference 1806-6172, broke off in the plug.".
Additional Manufacturer Narrative
Please note correction to b2 and d3.The reported event could be confirmed, since the extractor is broken as complained.The device inspection revealed the following: the visual inspection has shown that the tip of the extractor is broken off, no fragments were returned for evaluation.The lateral view of the breakage shows that the fracture face is oblique, which indicates that the device was exposed to high lateral stress when the breakage occurred.The microscopic view of the fracture face has at the outside a twisted appearance which is a typical sign of a ductile overload fracture, with a slight permanent distortion of the material in counter-clockwise direction that ends in a subsequent 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.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 use related issue.The failure was caused by applying too high torque in combination with lateral stress onto the device, which did lead to a mechanical overload.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported by the sales rep, "surgeon encountered difficulties in the removal of a t2 tibia nail.It proved impossible to remove the obturator plug and, by extension, the nail despite the use of stryker extraction kits.A left-handed screwdriver, reference 1806-6172, broke off in the plug.".

• Brand Name: CONICAL EXTRACTOR, MALE, LEFT HAND IMPLANT EXTRACTION SET 4 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: 16685981
• Report Number: 0009610622-2023-00104
• Device Sequence Number: 20852990
• Product Code: LXH
• UDI-Device Identifier: 04546540510082
• UDI-Public: 04546540510082
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 06/23/2023

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 Model Number: 1806-6172
• Device Catalogue Number: 18066172
• Device Lot Number: KSS1870AL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2023
• Supplement Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2018
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown