MAUDE Adverse Event Report: STRYKER GMBH CONICAL EXTRACTOR, FEMALE, LEFT HAND IMPLANT EXTRACTION SET Ø6.3 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18066186
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
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: "broken conical screw extractor.".
Additional Manufacturer Narrative
The device inspection revealed the following: the extractor was not received broken as reported, and appears to be in good condition (no visible deformation, cracks or signs of intensive usage).Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance to the values in the material specification.However, an unknown broken screw was found stuck in the extractor.The unknown screw is broken and cannot be removed from the extractor.The other half of the screw was not returned.It was most likely broken during its extraction and got jammed.Despite being returned for evaluation, the unknown screw cannot be removed from the extractor because a removal is only with destructive forces possible and this would also damage the screw head with a potential laser marking head.In addition, large amounts of organic residues are visible in the gaps, which would lead to contamination of the tools and machines.In this regard, it is not possible to know if the screw is a stryker product ¿ and if so, which specific screw.In addition, it has been reported that the sales representative "has been unable to find out which implant had to be removed".The unidentified stuck screw appears to be extremely worn out.The fracture surface looks dull and fibrous, and the screw and threads are deformed.Due to these observations, the breakage pattern looks like a ductile fracture.This may have been caused by an excessive force applied to the screw during its removal, causing permanent distortion, subsequent fracture and therefore the screw getting stuck in the extractor.Based on investigation, the root cause was attributed to a user related issue.The event was probably caused by an excessive force applied to the screw during its removal.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.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "broken conical screw extractor." 07/17/2024 - additional information.A broken screw was found in the returned conical extractor.Based on the available information it is not possible to track down the returned screw to a potentially used system, it is even unknown if the screw is a stryker device.There is no indication about the used system in the provided information, even the body region where the scew was used is unknown.

• Brand Name: CONICAL EXTRACTOR, FEMALE, LEFT HAND IMPLANT EXTRACTION SET Ø6.3 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: 19563483
• Report Number: 0009610622-2024-00288
• Device Sequence Number: 18032435
• Product Code: LXH
• UDI-Device Identifier: 04546540510211
• UDI-Public: 04546540510211
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2024

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: 18066186
• Device Lot Number: K931310
• 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: 05/23/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2012
• 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