MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN T2 SUPRAPATELLAR NAIL; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number UNK_KIE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Non-union Bone Fracture (2369); Limb Fracture (4518)

Event Date 07/18/2019

Event Type  Injury  

Event Description

Maude report (b)(4) was received by stryker.It was reported on an unknown date that the patient underwent total knee arthroplasty surgery with a suprapatellar t2 nail.On an unknown date the patient fractured the femur again for unknown reasons and a nonunion was discovered.The patient then underwent open reduction interval fixation surgery using depuy synthes products.

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.Device remains in patient.

• Brand Name: UNKNOWN T2 SUPRAPATELLAR NAIL
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 14338497
• MDR Text Key: 293937105
• Report Number: 0009610622-2022-00175
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_KIE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female