MAUDE Adverse Event Report: STRYKER TRAUMA KIEL NAIL ADAPTER T2 TIBIA SPI; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 18061402

Device Problem Sticking (1597)

Patient Problem No Information (3190)

Event Date 10/11/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the nail holding bolt got stuck inside nail adapter while trying to load the nail to the adapter.Nail holding bolt initially would seat flush with the adapter while threaded into the nail.Upon trying to un thread from the nail, the surgeon had to use maximum effort to get the bolt to turn in the slightest amount.After eventually getting the nail off of the bolt, the surgeon had to attach nail extraction rod to the nail holding bolt and use a mallet to back slap the bolt out of the adapter.The surgeon tried to put the bolt back in to re attach the nail and was un able to do so.Ultimately had to switch to a smith and nephew system and use their nail.This was the first time these instruments had ever been used.

Manufacturer Narrative

The evaluation revealed both instruments to be the primary products.No deviations were found during review of the manufacturing and inspection documents (dhr).The instruments were documented as faultless prior to distribution.An investigation was not possible because the instruments were not provided.The root cause 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.Device not return.

Event Description

It was reported that the nail holding bolt got stuck inside nail adapter while trying to load the nail to the adapter.Nail holding bolt initially would seat flush with the adapter while threaded into the nail.Upon trying to unthread from the nail, the surgeon had to use maximum effort to get the bolt to turn in the slightest amount.After eventually getting the nail off of the bolt, the surgeon had to attach nail extraction rod to the nail holding bolt and use a mallet to back slap the bolt out of the adapter.The surgeon tried to put the bolt back in to re attach the nail and was unable to do so.Ultimately had to switch to a smith and nephew system and use their nail.This was the first time these instruments had ever been used.

• Brand Name: NAIL ADAPTER T2 TIBIA SPI
• 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: 7009409
• MDR Text Key: 91788097
• Report Number: 0009610622-2017-00347
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 18061402
• Device Lot Number: K0B2888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other