MAUDE Adverse Event Report: STRYKER GMBH 3.0MM NON-THREADED KWIRE; SCREW, FIXATION, BONE

Model Number	KN1116
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "instratek mini 3.0 screw was inserted per the op-tech during an mpj fusion as an independent lag screw and the screw broke in half." additional information received - 12/16/2021: the surgical delay was approximately 30-40 minutes as (b)(6) wanted to remove both portions of the broken screw.Adverse consequences have not been brought to my attention.The patient had hard bone.Pre drilling was performed but not on the far cortex.(b)(6) used a shannon burr around the threads that were protruding from the 1st met head in order to give him room to grab onto the screw and pull it out.Irrigation was performed following this and dbm was inserted to fill the void.
Additional Manufacturer Narrative
The reported event could be confirmed, since the k-wire is stuck in the broken screw.The device inspection revealed the following: the visual inspection has shown that the k-wire is stuck in the received broken screw.The visible part of the k-wire is deformed and the wire is also deformed within the screw due to the deformation of screw shaft.The k-wire has some stress marks and an impression mark that was caused by any tool.Afterwards it cannot be defined if the damages at the wire occurred during insertion or extraction.The wire was cut with an cutting tool in the area of the screw breakage, most likely during the removal of the broken screw.A piece of the k-wire is also stuck in the fragment of the screw.A review of the device history was not possible because the lot number is unknown.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 received screw was strongly deformed before it broke, this deformation did also lead to a deformation of the k-wire and therefore the wire cannot be removed from the screw anymore.If more information is provided, the case will be reassessed.

• Brand Name: 3.0MM NON-THREADED KWIRE
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13873209
• Report Number: 0008031020-2022-00126
• Device Sequence Number: 4715972
• Product Code: HWC
• UDI-Device Identifier: 07613327363197
• UDI-Public: 07613327363197
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K120493
• 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
• Report Date (Section B): 03/23/2022

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: KN1116
• Device Catalogue Number: KN1116
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Female