MAUDE Adverse Event Report: STRYKER GMBH GUIDE WIRE HANDLE IMN INSTRUMENTS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	23510030
Medical Device Problem Codes	Break (1069); Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2023
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: "guide wire handle broke one "screw" of handle fell out and rendered handle unusable.Another tray had to be opened to complete the case.There was a 5 min surgical delay.Washed by hospital spd after case." all debris was removed from the surgical field/patient.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: one pin had come off from the metal clamping lever and slight signs of damage [hitting marks, scratches] at the area could be verified.The pin was not returned.Visual inspection revealed the drill hole, as the counterpart of missing pin, shows traces of intended press-fit.Thus, a dimensional inspection could not be performed safely.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 labelling did not indicate any abnormalities.Based on investigation of former complaints the event was identified being design related and is already covered by a nc / capa.Nc was filed and a capa triggered.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.
Event or Problem Description
As reported: "guide wire handle broke one "screw" of handle fell out and rendered handle unusable.Another tray had to be opened to complete the case.There was a 5 min surgical delay.Washed by hospital spd after case." all debris was removed from the surgical field/patient.

• Brand Name: GUIDE WIRE HANDLE IMN INSTRUMENTS
• 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: 18438060
• Report Number: 0009610622-2024-00012
• Device Sequence Number: 20724805
• Product Code: LXH
• UDI-Device Identifier: 07613327361674
• UDI-Public: 07613327361674
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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): 03/27/2024

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: 23510030
• Device Lot Number: KME916310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2023
• Supplement Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2021
• 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