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

Catalog Number UNK_KIE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Failure of Implant (1924)

Event Date 01/01/2012

Event Type  Injury  

Manufacturer Narrative

This complaint has been reported during a literature review performed by the post market surveillance group. The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available. More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event. The device history record could not be reviewed because the affected lot number was not communicated. If any further information is provided, the investigation report will be updated. Device disposition is unknown.

Event Description

The manufacturer became aware of a pmcf report from (b)(6). The title of this report is ¿a post- market clinical follow-up (pmcf) of the treatment of tibial shaft fractures with the t2 tibial nail. ¿ which is associated with the 'stryker t2 tibial nailing system¿. Within that report, post-operative complications/ adverse events were reported which occurred between 2012 - 2017. It was not possible to ascertain specific device catalog or patient information from the report, 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 60 complaints were initiated retrospectively for different adverse events mentioned in the report. This product inquiry addresses nonunion and nail exchange. The pmcf report states, "the thirty eighth case experienced a traumatic auto vs pedestrian accident was left with head lacerations, left shoulder abrasions, and left leg deformity below the knee. Approximately a month after the accident, while still hospitalized, a deep vein thrombosis formed in the left and right upper extremity. The hospital admission ended up lasting two months and there was complication in treating either thrombosis. The tibial injury went to nonunion and a nail exchange was done 11 months post op. Consolidation was reached 16 months after the nail exchange. ".

• Brand Name: UNKNOWN T2 TIBIA NAIL
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 9010534
• MDR Text Key: 161794053
• Report Number: 0009610622-2019-00674
• Device Sequence Number: 1
• Product Code: HSB
• 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

• Type of Report: Initial
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK_KIE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/22/2019
• 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 Treatment Data

Date Received: 09/12/2019 Patient Sequence Number: 1