MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 31251180S

Device Problems Device Markings/Labelling Problem (2911); Packaging Problem (3007)

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

Event Date 08/20/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The gamma-nail was wrongly packed and it was wrongly labeled.Instead of a 125° gamma-nail there was a 130° gamma-nail inside.It was labeled as 125° nail.

Manufacturer Narrative

The reported event that trochanteric nail kit, ti gamma3® ø11x180mm x 125° was alleged of 'labelling - mislabelling' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by a mix-up in the hospital, probably during the checking phase of the devices.Indeed, the tracing of the two lot numbers shows that a transaction was made to the customer for lot k0592bb on the 14th of august 2018, and another one for lot k04c818 was made on the 13th of august 2018.The two lots were manufactured 6 days apart, which excludes a mix-up at the manufacturing site.A review of the sticker history was performed: for lot # k0592bb: 46 devices were released on the 20 th of july 2018.During manufacturing, 47 box stickers were printed, 46 were stuck on the product boxes, 1 was archived.It is thus not possible for the sticker of lot# k0592bb to have ended up on the box of lot# k04c818.For lot # k04c818: 47 devices were released on the 26th of july 2016.During manufacturing, 48 box stickers were printed, 47 were stuck on the product boxes, 1 was archived.It is thus not possible for the sticker of lot# k04c818 to have ended up on the box of lot# k0592bb.Furthermore, a review of the sales shows that the two lots were distributed to the same hospital.The transaction dates for the two lots were one day apart, which presses the fact that the mix up could probably have happened in the hospital during checkings of the devices.The device inspection revealed the following: 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.Device was not returned.

Event Description

The gamma-nail was wrongly packed and it was wrongly labeled.Instead of a 125° gamma-nail there was a 130° gamma-nail inside.It was labeled as 125° nail.

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM 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
• MDR Report Key: 7883244
• MDR Text Key: 120579899
• Report Number: 0009610622-2018-01051
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540375070
• UDI-Public: 04546540375070
• 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: 11/15/2018

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: 06/30/2023
• Device Catalogue Number: 31251180S
• Device Lot Number: K0592BB
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/14/2018
• Initial Date Manufacturer Received: 08/21/2018
• Initial Date FDA Received: 09/17/2018
• Supplement Dates Manufacturer Received: 10/18/2018
• Supplement Dates FDA Received: 11/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other