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

Catalog Number	13201010
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/11/2018
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
It was reported that in removing a gamma nail from patient's left femur, a metal ring on the end of the targeter broke off and fell in the patient.The breakage was not noticed and was not caught with intra-operative x-rays.Post operative x-rays revealed the presence of the ring.The patient is due to have a total knee implant in the future, surgeon's plan is to remove the ring at that time.While the targeter is available for return, the ring currently remains in the patient.
Additional Manufacturer Narrative
The reported event that target device, g3 plus gamma3® was alleged of issue (g3 target device - detachment of c-ring) could be confirmed since the device was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: visual inspection: the c ring was found to be missing in the returned device.C ring was found in the patient in the x-rays shared.Clinical opinion was taken for the patient shared by the x-ray.¿usually from the size and the shape of the body the ring is not expected to affect the tissue and the bone of the patient any further.However, it is localized right lateral to the tip of the greater trochanter.There is a bursa located and the tractus iliotibialis is passing that region.There are patients who show chronic inflammation of that area.This can be promoted by a foreign body.In such a case a removal might be necessary, but it is usually not urgent.Based on investigation, the root cause was attributed to be user related (misuse or mishandling during sterilization/cleaning or previous surgeries) it cannot be excluded that the missing c-ring was detached prior to the surgery during the cleaning process to achieve a proper cleaning result with the target device.During detachment the ring may have been deformed which may have affected the secure fit of the ring (loosening).A review of the labeling did not indicate any abnormalities.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported that in removing a gamma nail from patient's left femur, a metal ring on the end of the targeter broke off and fell in the patient.The breakage was not noticed and was not caught with intra-operative x-rays.Post operative x-rays revealed the presence of the ring.The patient is due to have a total knee implant in the future, surgeon's plan is to remove the ring at that time.While the targeter is available for return, the ring currently remains in the patient.

• 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: 7756109
• Report Number: 0009610622-2018-00525
• Device Sequence Number: 1118698
• Product Code: LXH
• UDI-Device Identifier: 07613154972173
• UDI-Public: 07613154972173
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 13201010
• Device Lot Number: KME905547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 08/07/2018
• Supplement Report FDA Received Date: 01/08/2019
• 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
• Patient Age: 80 YR