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
Health Effect - Clinical Code	No Code Available (3191)
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 implant breakage.Two (case id 62) out of 3 cases.The pmcfr states: ¿in 3 cases (case 20,62 and 71) breakage of the material occurred.The breakage was situated on the locking screws and never on the nail itself.In the second case (case 62) it was a transverse fracture (32-a) in a heavy 70 years lady.She is 1,63m in height for a weight 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°
• 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: 7710515
• Report Number: 0009610622-2018-00373
• Device Sequence Number: 789926
• Product Code: HSB
• UDI-Device Identifier: 07613153316961
• UDI-Public: 07613153316961
• 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: 18471136S
• Device Lot Number: K0DADEB
• 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: 70 YR
• Patient Weight: 96