MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TIBIAL NAIL T2 ALPHA? TIBIA Ø11X345MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23411134S
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/05/2019
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 remains implanted.
Event or Problem Description
This information was received via an early product surveillance surgeon survey.It was reported that surgeon has implanted a ø11x345mm t2 alpha tibial nail in static locking mode via the suprapatellar approach in the treatment of a simple extraarticular fracture in the distal tibia (ao classification: 43-a1).Doctor's feedback were mixed, with neutral ratings on a couple of evaluation items (i.E., non-touch technique, friction lock of the targeting arm, overall satisfaction with t2 alpha tibial nail).Furthermore, he indicated to be ¿dissatisfied¿ with the final position of the nail and rated the operative technique to be ¿uncomprehensive¿.In addition, he described an issue as part of the provided comments, see as follows: ¿fracture extension as nail inserted through isthmus creating a longer fracture." patient adverse consequences due to this is additional fracture.

• Brand Name: TIBIAL NAIL T2 ALPHA? TIBIA Ø11X345MM
• 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: 8554775
• Report Number: 0009610622-2019-00228
• Device Sequence Number: 19391310
• Product Code: HSB
• UDI-Device Identifier: 07613327290738
• UDI-Public: 07613327290738
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K180436
• 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): 04/26/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 23411134S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 04/26/2019
• 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: Other