MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, STST, RIGHT GAMMA3® Ø11X340MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 42250340S

Device Problems Difficult to Insert (1316); Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/23/2016

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed, any additional information will be reported in a supplemental report.

Event Description

The customer reported that: " during the surgery it was not possible to retrieve the nail holder from the long nail once it was in place and locked.It was not possible to put another gamma long nail with the same dimension since there is only 1 reference of the implant".

Manufacturer Narrative

Evaluation revealed the long nail and the nail holding screw to be the primary products.The target device returned is considered to be an associated product.As mechanical properties of material and dimensions were within specified tolerances we exclude material and manufacturing deviations.Performed pre-op check revealed the returned devices being fully functional.During pre-op check, the three returned devices could be assembled and disassembled without excessive force as intended.The subject of the reported event could not be reproduced.Signs of seizing / fretting corrosion were not found on the items.The threads of nhs and nail are in good condition.Referring to the subject of the complaint it cannot be excluded that the nhs had been screwed in the nail with excessive force.Possibly, in this case the torsional force had not been applied constantly to the nhs but with a quick movement which would explain the relatively high loosening torque whilst disassembling the items.All relevant information for a comprehensive investigation has been repeatedly requested, but it was not provided.Thus, the investigation is based on the details given within product inquiry, only.However, based on the information given an exact root cause of the reported event could not be determined.Review of complaint history, capa databases and risk analysis did not identify any discrepancies.There are no open actions in place related to the reported event for the subject product(s).No non-conformity was identified.

Event Description

The customer reported that: " during the surgery, it was not possible to retrieve the nail holder from the long nail once it was in place and locked.It was not possible to put another gamma long nail with the same dimension since there is only 1 reference of the implant".

• Brand Name: LONG NAIL KIT R2.0, STST, RIGHT GAMMA3® Ø11X340MM X 125°
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5523508
• MDR Text Key: 41315866
• Report Number: 0009610622-2016-00163
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K034343
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 03/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 42250340S
• Device Lot Number: KU53327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/02/2016
• Initial Date FDA Received: 03/24/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/01/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2015
• 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): Other