MAUDE Adverse Event Report: STRYKER TRAUMA KIEL RECONSTRUCTION NAIL R2.0, TI, LEFT T2 RECON Ø11X400 MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18461140S
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	01/01/2014
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The manufacturer became aware of a post market clinical follow-up (pmcf) from (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 delayed or nonunion.Seven (case id 22) out of 7 cases.As per the pmcfr, the treatment was done by a new nailing after reaming.A new t2 nail was used with a antegrade proximal locking.

• Brand Name: RECONSTRUCTION NAIL R2.0, TI, LEFT T2 RECON Ø11X400 MM X 125°
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 7710749
• Report Number: 0009610622-2018-00375
• Device Sequence Number: 13641186
• Product Code: HSB
• UDI-Device Identifier: 07613153316688
• UDI-Public: 07613153316688
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K032898
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 18461140S
• Device Lot Number: K0EABA5
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2018
• Initial Report FDA Received Date: 07/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR