MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNK T2 TIBIA NAIL; IMPLANT

Catalog Number UNK_KIE

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Irritation (1941); Implant Pain (4561)

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 (b)(6) 2018 and is associated with the t2 tibial nailing system.Within that publication, postoperative complications/ adverse events were reported, which occurred between (b)(6) 2012 to (b)(6) 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 hardware irritation.2 out of 6 cases.The (b)(6) states: ¿subject a.2 was a (b)(6) year old caucasian male, with a left open tibia fracture (gustillo iiib) after a motor vehicle accident.Concurrent multi-trauma and organ injury was present on admission; orthopaedic injuries also present on admission included right hip acetabular fracture and femoral head fracture, left open distal femur fracture.Subject has a history significant for previous tobacco use.Subject underwent serial irrigation and debridements, initial external fixation placement, antibiotic bead placement and removal, and final definitive fixation (34 days from the external fixation placement).A t2 tibia nail was placed in the transverse only mode (medial to lateral) with 3 distal screws across 2 planes.Subject spent 42 days in the hospital from the time of initial injury and was discharged on post-op day (pod) #8 after the definitive surgery to an acute rehabilitation center, non-weightbearing.Subject during the follow up period, chronologically experienced wound healing disturbances on 2 occasions, nonunion, and then hardware irritation.Hardware irritation occurred 251 days after definitive surgery.At his 6 month follow up visit, subject complained of medial skin breakdown over the medial aspect of the left ankle near the distal interlocking screw.Subject returned for surgery with an irrigation and debridement with removal of hardware.¿.

Manufacturer Narrative

Please note new information in b2 and h6 (device code, clinical signs code and health impact code) sections.

Event Description

The manufacturer became aware of a post market clinical follow-up (pmcf) from inova fairfax medical campus (ifmc).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 (b)(6) 2012 to(b)(6) 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 hardware irritation.2 out of 6 cases.The pmcfr states: ¿subject a.2 was a 59 year old caucasian male, with a left open tibia fracture (gustillo iiib) after a motor vehicle accident.Concurrent multi-trauma and organ injury was present on admission; orthopaedic injuries also present on admission included right hip acetabular fracture and femoral head fracture, left open distal femur fracture.Subject has a history significant for previous tobacco use.Subject underwent serial irrigation and debridements, initial external fixation placement, antibiotic bead placement and removal, and final definitive fixation (34 days from the external fixation placement).A t2 tibia nail was placed in the transverse only mode (medial to lateral) with 3 distal screws across 2 planes.Subject spent 42 days in the hospital from the time of initial injury and was discharged on post-op day (pod) #8 after the definitive surgery to an acute rehabilitation center, non-weightbearing.Subject during the follow up period, chronologically experienced wound healing disturbances on 2 occasions, nonunion, and then hardware irritation.Hardware irritation occurred 251 days after definitive surgery.At his 6 month follow up visit, subject complained of medial skin breakdown over the medial aspect of the left ankle near the distal interlocking screw.Subject returned for surgery with an irrigation and debridement with removal of hardware.¿.

• Brand Name: UNK T2 TIBIA NAIL
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 7675457
• MDR Text Key: 113627169
• Report Number: 0009610622-2018-00295
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2018
• 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
• Date Manufacturer Received: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR