MAUDE Adverse Event Report: STRYKER TRAUMA KIEL RECONSTRUCTION NAIL R2.0, TI, RIGHT T2 RECON Ø11X360 MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 18471136S

Device Problem Break (1069)

Patient Problems Sepsis (2067); Non-union Bone Fracture (2369)

Event Date 01/01/2014

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device not available to stryker.

Event Description

The manufacturer became aware of a post market clinical follow-up (pmcf) from (b)(6) hospital (b)(6).The title of this report is ¿analysis of the t2 recon nail used with the antegrade locking mode¿ which was released in june 2018 and is associated with the t2 recon nailing system.Within that report, postoperative complications/ adverse events were reported, which occurred between january 2014 and november 2017.Based on the available device and patient information and a review of complaint handling database it was revealed that the events have not been reported by the hospital or by the author of the report, therefore 15 complaints were initiated retrospectively for different adverse events mentioned in the journal.This product inquiry addresses septic nonunion discovered from the event of case id (b)(6).One out of 1 case.The pmcfr states: ¿in the second case (case (b)(6)) it was a transverse fracture (32-a) in a heavy (b)(6) years lady.She is 1,63 m in height for a weight of (b)(6) kg (bmi of (b)(6)).The breakage of all three locking screws was observed.In fact a septic nonunion was observed and a revision surgery was performed 142 days after the initial surgery.All the broken screws were removed (18965050s-k05d869;18965050s-k0af9e2;18965042s-k074ffc), the nail was also removed (18471136s-k0dadeb) the medullary canal was reamed and a t2 a/r nail was then used.Antibiotics were used during 4 months.¿.

• Brand Name: RECONSTRUCTION NAIL R2.0, TI, RIGHT T2 RECON Ø11X360 MM X 125°
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer Contact: melissa guattery ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7710742
• MDR Text Key: 114727515
• Report Number: 0009610622-2018-00377
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07613153316961
• UDI-Public: 07613153316961
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K032898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 18471136S
• Device Lot Number: K0DADEB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2018
• 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 Age: 70 YR