MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, STST, LEFT GAMMA3® Ø11X360MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 43250360S

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/11/2020

Event Type  malfunction  

Manufacturer Narrative

The reported device is not cleared in the us, however similar devices are cleared in the us.Upon completion of investigation, additional information will be provided in a supplemental report.Device remains implanted; packaging will be evaluated.

Event Description

Customer reported that : "i wanted to inform you of a quality defect found on the packaging of a gamma 3 nail.When using the nail, some of the white packaging foam remained on the device.[.] the implant was used after cleaning.".

Manufacturer Narrative

Contrary to the statement in section h10 of the initial report, the reported device is cleared for sale in the us.The reported event could not be confirmed, since the device was not returned for evaluation and thus, limited to the device packaging returned.An empty product packaging was returned for evaluation with an evidently damaged foam block.An inspection of the packaging in original condition was not possible as the clear blister is already opened.Finally, an inspection of the nail in question could not be performed as the implant was used and no evidences [such as an image of the alleged contaminated nail] was provided for investigation.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.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.If any further information is provided, the investigation report will be updated.

Event Description

Customer reported that : "i wanted to inform you of a quality defect found on the packaging of a gamma 3 nail.When using the nail, some of the white packaging foam remained on the device.[.] the implant was used after cleaning.".

• Brand Name: LONG NAIL KIT R2.0, STST, LEFT GAMMA3® Ø11X360MM 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; DE D-24232
• MDR Report Key: 9808948
• MDR Text Key: 191550127
• Report Number: 0009610622-2020-00095
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K043431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 43250360S
• Device Lot Number: KU71783
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1