MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 11X380MM X 125; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 34251380S

Device Problems Separation Failure (2547); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/03/2021

Event Type  malfunction  

Manufacturer Narrative

Upon completion of the investigation, additional information will be provided in a supplemental report.

Event Description

It was reported: "the doctor was performing an intramedullary gamma nail on the patient's right side.During the impaction of the nail the locking bolt beacon cold welded to the nail and was unable to separate the targeted from the nail.A new targeter tray was opened with another locking bolt as well as a new nail.The procedure was complete without further incident".

Event Description

It was reported: "the doctor was performing an intramedullary gamma nail on the patient's right side.During the impaction of the nail the locking bolt beacon cold welded to the nail and was unable to separate the targeted from the nail.A new targeter tray was opened with another locking bolt as well as a new nail.The procedure was complete without further incident.".

Manufacturer Narrative

The reported event could be confirmed, since the devices could not be disassembled as designed.The device inspection revealed the following: during the visual inspection no damage at the nail could be detected, the device is in a good condition.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by an excessive, inappropriate hit with a hammer onto the nail holding screw while the devices were assembled.The received nail itself did not contribute to the complained malfunction.In this relation we would like to point out the instructions for use with following statement: [do not hit instruments unless they are specifically intended for impaction.Never hit targeting devices or elastosil handles other than those with an integrated strike.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 11X380MM 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; GM D-24232
• MDR Report Key: 11899085
• MDR Text Key: 260113089
• Report Number: 0009610622-2021-00531
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K034002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/14/2021

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 Catalogue Number: 34251380S
• Device Lot Number: K056D4A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Initial Date Manufacturer Received: 05/03/2021
• Initial Date FDA Received: 05/27/2021
• Supplement Dates Manufacturer Received: 08/26/2021
• Supplement Dates FDA Received: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 18 YR