MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGET DEVICE T2 RECON; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 18063100

Device Problems Accessory Incompatible (1004); Break (1069); Entrapment of Device (1212)

Patient Problems Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)

Event Date 11/23/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Customer reported that whilst using t2 recon nail, the registrar and scrub tested to see if they lined up with the jig.They took an x-ray and everything seemed ok, therefore proceeded to drill through the canal.When looking at the lateral view x-ray, they realized the screw missed the nail.They removed the 2 screws and adjusted the nail to try again, but the k-wire hit the nail and small piece of wire broke off.This was left in the patient and they decided not to continue this method.They successfully completed the surgery using antegrade technique by putting the screw through the lesser trochanter.There was a 45 minute delay.Delay of 45 minutes, unintended metal (k-wire) left in patient.

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.This is the first reported case with this lot number.A review of the labeling did not indicate any abnormalities.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

Customer reported that whilst using t2 recon nail, the registrar and scrub tested to see if they lined up with the jig.They took an x-ray and everything seemed ok, therefore proceeded to drill through the canal.When looking at the lateral view x-ray, they realized the screw missed the nail.They removed the 2 screws and adjusted the nail to try again, but the k-wire hit the nail and small piece of wire broke off.This was left in the patient and they decided not to continue this method.They successfully completed the surgery using antegrade technique by putting the screw through the lesser trochanter.There was a 45 minute delay.Delay of 45 minutes, unintended metal (k-wire) left in patient.

• Brand Name: TARGET DEVICE T2 RECON
• 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: 8359171
• MDR Text Key: 139327038
• Report Number: 0009610622-2019-00079
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540654939
• UDI-Public: 04546540654939
• Combination Product (y/n): N
• PMA/PMN Number: K102992
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/01/2019

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: 18063100
• Device Lot Number: KME903313
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/15/2019
• Initial Date Manufacturer Received: 02/06/2019
• Initial Date FDA Received: 02/21/2019
• Supplement Dates Manufacturer Received: 04/09/2019
• Supplement Dates FDA Received: 05/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other