MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LAG SCREW, RECON T2 RECON Ø6.5X110 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 18976110S

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Unspecified Infection (1930)

Event Date 02/04/2011

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.

Event Description

The manufacturer became aware of adverse events from the (b)(6) hip fracture register.The title of this report is ¿t2 recon in the (b)(6) hip fracture register¿ which is associated with the t2 recon nailing system, within that report, post-operative complications/ adverse events were reported, which occurred between 2009 and 2017.A review of the complaint handling database revealed that the events have not been reported previously to stryker, therefore 13 events were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses revision surgery due to deep infection.The patient received a drainage.It was also indicated that patient passed away within 60 days since the revision surgery however the cause and the date of the death will not be disclosed.

• Brand Name: LAG SCREW, RECON T2 RECON Ø6.5X110 MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7777585
• MDR Text Key: 116921258
• Report Number: 0009610622-2018-00700
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540384829
• UDI-Public: 04546540384829
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K032898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 18976110S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2018
• 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