MAUDE Adverse Event Report: STRYKER TRAUMA KIEL EXTRACTION HOOK, LARGE IMPLANT EXTRACTION SET; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-6162
Medical Device Problem Code	Inadequate Instructions for Healthcare Professional (1319)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.The device is not defective, the problem is with the extraction instructions.
Event or Problem Description
As reported: "according to our extraction instructions, broken gamma3 nails can be removed with a large extraction hook.Based on this information, the customer ordered a large hook for nail removal.During the surgery, it was discovered that the information in the brochure was incorrect and the extraction hook did not fit into the nail.For this reason, the duration of the operation was extended by one hour and the removal of the nail had to be performed using an alternative method.".
Additional Manufacturer Narrative
Correction - please refer to h6 (results & conclusion codes).The reported event could not be confirmed since the information in the brochure is not incorrect.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.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by using a large extraction hook for the removal a gamma3 titanium nail.The provided operative technique does specify in the product description section that "extraktionshaken, klein" (extraction hook, small) used for the titanium version "gamma3 (ti)" and the "extraktionshaken, gross" (extraction hook, large) is used for the stainless steel version "gamma3 (stst)".In relation to the received operative technique, which was released in may 2010, it can be mentioned that on the homepage https://ifu.Stryker.Com a current version, of the implant extraction set operative technique is available.This version does also contain following statement: "caution implants can be subject to change.This can impact the compatibility of extraction instruments.It is therefore required to start the implant extraction with a complete extraction set in order to have access to alternative instruments." if the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "according to our extraction instructions, broken gamma3 nails can be removed with a large extraction hook.Based on this information, the customer ordered a large hook for nail removal.During the surgery, it was discovered that the information in the brochure was incorrect and the extraction hook did not fit into the nail.For this reason, the duration of the operation was extended by one hour and the removal of the nail had to be performed using an alternative method.".

• Brand Name: EXTRACTION HOOK, LARGE IMPLANT EXTRACTION SET
• 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: 16128163
• Report Number: 0009610622-2023-00006
• Device Sequence Number: 12671506
• Product Code: LXH
• UDI-Device Identifier: 04546540510006
• UDI-Public: 04546540510006
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 03/07/2023

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: 1806-6162
• Device Catalogue Number: 18066162
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2022
• Supplement Date Received by Manufacturer: 02/08/2023
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Female