MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNK T2 TIBIAL PROXIMAL SCREW; IMPLANT

Catalog Number UNK_KIE

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Date 11/01/2012

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).The title of this report is ¿a post-market clinical follow-up (pmcf) of the treatment of tibial fractures with the t2 tibial nailing system¿ which was published in june 2018 and is associated with the t2 tibial nailing system.Within that publication, postoperative complications/ adverse events were reported, which occurred between november 2012 to september 2017.It was not possible to ascertain specific device or patient information from the article, 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 66 complaints were initiated retrospectively for different adverse events mentioned in the journal.This product inquiry addresses screw backout.Two out of 2 cases.The pmcfr states: ¿subject was a (b)(6) caucasian female, with a left closed tibia fracture after being a pedestrian struck while crossing the street.Health history was significant for osteopenia.No other concurrent injuries or orthopaedic injuries.Subject went to the operating room and had a t2 tibia nail with proximal screws in the transverse (medial to lateral and lateral to medial) and oblique modes with 2 distal screws in 1 plane.Subject was discharged on pod #2 to acute rehabilitation, toe-touch weightbearing.At a follow-up visit, pod #50, subject had the distal of the proximal screws, the transverse one, seems to have baked out.Recommended to monitor.At the 3 month follow-up visit, the screw back-out was noted to be stable and did not back out any further.At the 13 month follow-up, subject went on to have bone consolidation and 2 proximal screws were prominent but not tenting or causing subject any complaints.Subject was discharged from follow-up.¿.

• Brand Name: UNK T2 TIBIAL PROXIMAL SCREW
• Type of Device: IMPLANT
• 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: 7704133
• MDR Text Key: 114548873
• Report Number: 0009610622-2018-00334
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_KIE
• 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: 82 YR