MAUDE Adverse Event Report: STRYKER GMBH RECON LAG SCREWDRIVER ROD IMN INSTRUMENTS

Catalog Number	23510221
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
The splitting recon lag screw bit/rod set did not lock and made the endcap filthy.
Additional Manufacturer Narrative
Correction: please refer to h3 - device evaluated by mfg.The reported event could not be confirmed since the returned devices are conforming to specifications and fully functional.The device inspection revealed the following: the spreading recon lag screwdriver and the corresponding rod were returned for evaluation.The recon lag screwdriver rod is in a very used condition, the head has wear marks allover, the coating at the tip is not present anymore and the thread is worn.The device was obviously often and intense used.The spreading recon lag screwdriver is in a good condition.There are slight wear marks visible at the hexagon, but there is no indication that these marks could have an influence on the functionality.A functional test with a handle was performed.The screwdriver and the rod could be assembled and disassembled without any issues.The prongs of the spreading hexagon did expand as intended when the rod was tightened.A end cap was used for a functional test and the cap did firmly hold on the screwdriver when the rod was tightened, no play could be observed.In the final position with the cap attached was still a gap of about 1mm between the end of the handle and the head of the rod.This shows that the rod was not in the end position when the cap was fin the hold position and that there was still room for further spreading.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.The reported malfunction could not be reproduced with the returned devices, to define the root cause of the event all other during the procedure used devices would be needed for evaluation.If more information is provided, the case will be reassessed.
Event or Problem Description
The splitting recon lag screw bit/rod set did not lock and made the endcap filthy.

• Brand Name: RECON LAG SCREWDRIVER ROD IMN INSTRUMENTS
• Common Device Name: SCREWDRIVER
• 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: 20105711
• Report Number: 0009610622-2024-00826
• Device Sequence Number: 7664726
• Product Code: HXX
• UDI-Device Identifier: 07613327361858
• UDI-Public: (01)07613327361858(11)190827(10)K09A040
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 10/15/2024

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: 23510221
• Device Lot Number: KP433903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 08/30/2024
• Supplement Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2019
• 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 Age: 88 YR
• Patient Sex: Female