MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN ROD; IMPLANT

Catalog Number UNK_KIE

Device Problem Fracture (1260)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 10/01/2018

Event Type  Injury  

Manufacturer Narrative

The information in this report was provided by stryker legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Device remains implanted in patient.

Event Description

Patient reported he had a double compound fracture on his lower left leg in (b)(6) 2017, he had 1 rod inserted the day of the accident and the other rod 1-2 months later.Patient has been experiencing excruciating pain since his surgery.Patient started work a year after his surgery in (b)(6) 2018.Patient started his shift at work, by the end of the night the patient was limping, could not put weight on his leg and was experiencing excruciating pain.Patient went to the hospital where x-ray images were taken and was told the rod was broken.Patient stated that his other rod is bent and he can feel it to the touch and it also looks like it is about to break.Patient has not been revised as he cannot afford going to see another surgeon.

• Brand Name: UNKNOWN ROD
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• Manufacturer Contact: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 10525160
• MDR Text Key: 206719004
• Report Number: 0009610622-2020-00503
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_KIE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2020
• 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): Other
• Patient Age: 47 YR
• Patient Weight: 77