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

Catalog Number	18063100
Health Effect - Clinical Codes	Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)
Date of Event	11/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 0009610622-2019-00079
• Device Sequence Number: 19168897
• Product Code: HSB
• UDI-Device Identifier: 04546540654939
• UDI-Public: 04546540654939
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K102992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 02/06/2019
• Supplement Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 02/21/2019
• Supplement Report FDA Received Date: 05/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other