MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN T2 FEMORAL NAIL; IMPLANT

Catalog Number UNK_KIE

Device Problem Separation Problem (4043)

Patient Problems Failure of Implant (1924); Implant Pain (4561)

Event Date 09/15/2020

Event Type  Injury  

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The device history record could not be reviewed because the affected lot number was not communicated.If any further information is provided, the investigation report will be updated.

Event Description

The manufacturer became aware of a post market clinical follow-up report received from university of (b)(4), in usa.The title of this report is ¿a retrospective data collection of the treatment of femur fractures with the t2 femoral nailing system¿ which is associated with the stryker ¿t2 femoral nailing system¿.This study includes research done on 52 patients requiring surgery between the period february 15, 2017 to september 1, 2019.It was not possible to ascertain specific device details from the report, or to match the events reported with previously reported complaints.Therefore, new complaint was initiated in the system for the post-operative complication mentioned in the report.This product inquiry addresses pain due to distal interlocking screw back out for which screw removal was performed.The report states: ¿patient fourteen who sustained a grade 3a femur fracture was discovered to have limb length discrepancy of the affected extremity as compared to the contralateral side.An attempt to correct the limb length intraoperatively was unsuccessful.The patient then returned to the operating room 2 days later for revision of the limb length inequality.Following the revision surgery, the patient was clinically identified to have symmetric limb lengths [reported separately].The patient then presented one month postoperatively with pain in his right knee as a result of a distal interlocking screw backing out.The patient returned to the operating room for hardware removal of the prominent interlocking screw.The pain has since resolved advised to follow-up on an as-needed basis.¿.

• Brand Name: UNKNOWN T2 FEMORAL NAIL
• Type of Device: IMPLANT
• 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: 10738069
• MDR Text Key: 213244550
• Report Number: 0009610622-2020-00610
• 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: study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2020
• 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): Required Intervention