MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN GAMMA3 LAG SCREW ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number UNK_KIE

Device Problem Fracture (1260)

Patient Problem Death (1802)

Event Date 11/17/2010

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The manufacturer became aware of adverse events from the norwegian hip fracture register. The title of this report is ¿gamma 3 in the norwegian hip fracture register¿ which is associated with the gamma3 locking nail system, within that report, post-operative complications/ adverse events were reported, which occurred between 1-jan-2005 and 31-dec-2016. A review of the complaint handling database revealed that the events have not been reported previously to stryker, therefore 290 complaints were initiated for the revision surgeries retrospectively for different adverse events mentioned in the report. This product inquiry addresses revision surgery due to new fracture around implant. The patient received a hip bipolar hemiarthroplasty. The 215 out of 290 cases. It was also indicated that patient died within 60 days of revision surgery however the cause and date of death will not be disclosed.

• Brand Name: UNKNOWN GAMMA3 LAG SCREW
• 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: 7781097
• MDR Text Key: 117123703
• Report Number: 0009610622-2018-01013
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: NO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature

Reporter Occupation

• Type of Report: Initial
• Report Date: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: UNK_KIE
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• 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 Treatment Data

Date Received: 08/14/2018 Patient Sequence Number: 1