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

Catalog Number UNK_KIE

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Injury (2348)

Event Date 01/01/2012

Event Type  Injury  

Manufacturer Narrative

This complaint has been reported during a literature review performed by the post market surveillance group.No product identification is possible.Based on the investigation results, no definitive relation could be established between the product and the reported failure adverse consequence.The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information will be provided.If further relevant information becomes available, the investigation will be reevaluated and resubmitted accordingly.Device disposition unknown.

Event Description

The manufacturer became aware of a pmcf from (b)(6), united states.The title of this report is ¿a retrospective data collection of the treatment of upper and lower extremity fractures with the t2 kids flexible nailing system.¿ which is associated with the stryker ¿t2 kids flexible nailing¿ system.Within that publication, post-operative complications/ adverse events were reported, which occurred from 2012 to 2017.It was not possible to ascertain specific patient & device details from the report, a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication, therefore 9 complaints were initiated retrospectively for adverse events mentioned in the report.This product inquiry addresses hardware prominence that required surgery for nail shortening & reinserted.3 out of 4 cases.The report states: ¿4/66 (6%) patients had hardware prominence that required surgery for nail shortening as the sole complication.[¿] [¿] so this was 4 nails identified ¿ all femur nails, no forearm ¿ that had the nail back out thru the skin, that had to be shortened and reinserted, but not removed b/c bone hadn¿t healed yet.¿.

• Brand Name: UNKNOWN T2 KIDS FLEXIBLE NAIL
• 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: kevin smith ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 9998706
• MDR Text Key: 193057905
• Report Number: 0009610622-2020-00181
• 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: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2020
• 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