MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 11X340MM X 130 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 3430-1340S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Exsanguination (1841); Perforation (2001)

Event Date 09/06/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

As reported: "i was made aware by another consultant of an event that occurred - where a gamma nail was implanted in the patient, however the tip-apex distance of the lag screw was wrong so the screw cut out and needed revision, patient started losing a large amount of blood and later was pronounced deceased in icu. The case and corresponding surgeon is now under investigation. ".

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 11X340MM X 130
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: kevin smith ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 10871616
• MDR Text Key: 217295377
• Report Number: 0009610622-2020-00717
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K034002
• 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: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 3430-1340S
• Device Catalogue Number: 34301340S
• 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: 10/26/2020
• 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: 11/19/2020 Patient Sequence Number: 1