MAUDE Adverse Event Report: STRYKER TRAUMA KIEL ADVANCED LOCKING SCREW IMN SCREWS Ø5X35MM; SCREW, FIXATION, BONE

Model Number	2361-5035S
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
It was reported: "during ap screw insertion to distal of the tibia, the screw became stuck in the nail.An attempt was made to remove it, but it was difficult and took 30 minutes.The surgery was completed without inserting any screws into the hole.".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.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.Finally, the use of a locking screw is mandatory and the ifu points out as following ¿the advanced locking screw must be inserted using reasonable force.To provide desired function and to avoid damaging the screw.If unreasonable insertion torque is noticed, stop insertion, turn the screw counterclockwise and then attempt to insert the screw.If unreasonable insertion torque is still noticed, remove the screw and proceed with a locking screw.¿ in case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.
Event or Problem Description
It was reported: "during ap screw insertion to distal of the tibia, the screw became stuck in the nail.An attempt was made to remove it, but it was difficult and took 30 minutes.The surgery was completed without inserting any screws into the hole.".

• Brand Name: ADVANCED LOCKING SCREW IMN SCREWS Ø5X35MM
• Common Device Name: SCREW, FIXATION, BONE
• 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: 13727591
• Report Number: 0009610622-2022-00087
• Device Sequence Number: 4623363
• Product Code: HWC
• UDI-Device Identifier: 07613327381597
• UDI-Public: 07613327381597
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191271
• 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): 06/07/2022

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: 2361-5035S
• Device Catalogue Number: 23615035S
• Device Lot Number: K0459DC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2022
• Supplement Date Received by Manufacturer: 05/12/2022
• Initial Report FDA Received Date: 03/10/2022
• Supplement Report FDA Received Date: 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2021
• 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 Sex: Unknown