MAUDE Adverse Event Report: STRYKER GMBH GUIDE WIRE WITH RULER TUBE IMN INSTRUMENTS Ø3X800 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	23513080S
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2024
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
It was reported that metal ring of ¿ruler tube,¿ in 3x800mm guide wire with ruler tube (2351-3080s) detached from plastic ruler leaving metal ring inside tibial canal.There was a delay of 30 minutes in the procedure.Surgeon was forced to perform additional steps to procedure to rectify the event.
Event or Problem Description
It was reported that metal ring of ¿ruler tube,¿ in 3x800mm guide wire with ruler tube (2351-3080s) detached from plastic ruler leaving metal ring inside tibial canal.There was a delay of 30 minutes in the procedure.Surgeon was forced to perform additional steps to procedure to rectify the event.Opening a previously irrigated fasciotomy site to insert a reduction finger retrograde at the fracture site to push the ring through the proximal opening of the tibia.
Additional Manufacturer Narrative
The reported event could be confirmed because the components were returned in separated condition.The device inspection revealed the following: from the guide wire with ruler tube imn instruments 03x800 mm only the lower transparent ruler tube was returned.The item had obviously been separated into 2 parts and was additionally bent in 2 edges, assumedly for transport purposes.The piece in front of the stryker-print was missing thus, the original lot could not be determined.The metal ring had been removed or had fallen off from distal end but was significantly damaged and deformed.The edges had become frayed and the initial round shape had become oval.The ring must have been mishandled after surgery because such damages would not have been accepted for surgery.Functional inspection: due to determined damages the item was no longer functional.Due to the damages, it could not be determined how the product¿s condition was prior to resp.During surgery.Dimensional inspection: internal diameter of the tube and external diameter of the ring could not be determined due to above damages.Incoming inspection documents shows all dimensions were within specs when distributed.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.In the case presented a patient had been treated using above ruler tube.It was reported that during usage, metal ring of ¿ruler tube,¿ in 3x800mm guide wire with ruler tube (2351-3080s) detached from plastic ruler leaving metal ring inside tibial canal.Delay in procedure was reported with 30 min.Surgeon forced to perform additional steps to procedure to rectify the event.The ring was removed during the surgery.The ruler tube is often over-inserted to judge nail length accommodating countersinking.It was presumed by the field staff the ring became loose on removal.Investigation revealed the returned product being within specifications and functional when distributed.Considering the rings deformation and damage it must have been miss-handled in excessive way.With available information a real root cause could not be determined.With available information a product deficiency was not verified.

• Brand Name: GUIDE WIRE WITH RULER TUBE IMN INSTRUMENTS Ø3X800 MM
• 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: 19441913
• Report Number: 0009610622-2024-00260
• Device Sequence Number: 8129190
• Product Code: LXH
• UDI-Device Identifier: 07613327361797
• UDI-Public: 07613327361797
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 23513080S
• Device Lot Number: KU155701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 06/01/2024
• Supplement Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 14 YR
• Patient Sex: Male
• Patient Weight: 64 KG