MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGET DEVICE, G3 PLUS GAMMA3®; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	13201010
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/10/2018
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
Primary procedure, right femur.It was reported that a ring came off of the targeter where it attaches to the nail while inside the patient.The surgeon was able to retrieve the ring with a reported surgical delay of less than 2 minutes.Rep was not present for the procedure.The rep has provided a picture of the targeter and the ring.The targeter is available for return (the nail was implanted), but the ring was lost by the hospital.No adverse consequences to patient due to surgical delay.
Additional Manufacturer Narrative
The reported event that target device, g3 plus gamma3® was alleged of 'instruments - broken, deformed, worn or scratched' could be confirmed.Based on investigation, the root cause was attributed to be user related.The c-ring was found deformed and was attached in a wrong position.This may have been caused by detachement for cleaning purposes by re-attachement in improper manner.The failure was caused by misuse.The device inspection revealed the following: the picture sent by the hospital shows indeed that the c-ring was disconnected from the targeter.The ring in question is highly deformed.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 or Problem Description
Primary procedure, right femur.It was reported that a ring came off of the targeter where it attaches to the nail while inside the patient.The surgeon was able to retrieve the ring with a reported surgical delay of less than 2 minutes.Rep was not present for the procedure.The rep has provided a picture of the targeter and the ring.The targeter is available for return (the nail was implanted), but the ring was lost by the hospital.No adverse consequences to patient due to surgical delay.

• Brand Name: TARGET DEVICE, G3 PLUS GAMMA3®
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 7567242
• Report Number: 0009610622-2018-00233
• Device Sequence Number: 2029539
• Product Code: LXH
• UDI-Device Identifier: 07613154972173
• UDI-Public: 07613154972173
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• 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): 11/12/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 13201010
• Device Lot Number: KME906942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Initial Date Received by Manufacturer: 05/10/2018
• Supplement Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 06/04/2018
• Supplement Report FDA Received Date: 11/12/2018
• 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
• Patient Age: 79 YR
• Patient Weight: 76