MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGET DEVICE GAMMA3®; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 1320-0111

Device Problems Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 10/11/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

At the time the surgeon was going to implant the gamma nail, the arch became trapped in the nail entry thread.At the time the surgeon tried to remove the arch, it had to be removed with the implant included.Aditionally, it was necessary to remove all screws that were place into the patient.To finished the surgery it was necessary to open a new implant and the patient had to receive double anesthesia for the operative time.

Event Description

At the time the surgeon was going to implant the gamma nail, the arch became trapped in the nail entry thread.At the time the surgeon tried to remove the arch, it had to be removed with the implant included.Additionally, it was necessary to remove all screws that were place into the patient.To finished the surgery it was necessary to open a new implant and the patient had to receive double anesthesia for the operative time.

Manufacturer Narrative

Additional information resulting from dis-assembling the stuck devices: the reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.The device inspection revealed the following: the devices were received in a stuck state.After inspecting the overall appearance, it was observed that the target device was severely damaged around the head region possibly with a sharp tool during the surgery (however not related with the current event).The nail holding screw was stuck inside the target device with its distal part firmly attached to the nail.One of its side was dented, which possibly would have been caused in an attempt to disassemble it initially.However, after dis-assembling the devices, the devices were re-inspected thoroughly.No significant findings (other than reported above) could be observed which could lead to the cause of the failure as reported.After dis-assembling a functional inspection was performed with the returned nail and nail holding screw.As the target device was damaged from the head region, to assemble, a sample targeting device was used.Upon inspection, the devices were functionally ok.The nail holding screw could be easily fit into the target device and the nail.All the functions, including drilling configuration could be achieved without any failure.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.As per the above investigation, even after dis-assembling the device, no exact root cause could be determined which could possibly lead to the failure as reported.If any further information is provided, the complaint report will be updated.

Event Description

At the time the surgeon was going to implant the gamma nail, the arch became trapped in the nail entry thread.At the time the surgeon tried to remove the arch, it had to be removed with the implant included.Aditionally, it was necessary to remove all screws that were place into the patient.To finished the surgery it was necessary to open a new implant and the patient had to receive double anesthesia for the operative time.

Manufacturer Narrative

Correction: refer to g1 (mfg site) the reported event could be confirmed.The device inspection revealed the following: the devices namely target device, nail and nail holding screw were received in a stuck state.After inspecting the overall appearance, it was observed that the target device was severely damaged around the head region possibly with a sharp tool during the surgery (however not related with the current event).The nail holding screw was stuck inside the target device with its distal part firmly attached to the nail.One of its side was dented, which possibly would have been caused in an attempt to disassemble it initially.The nail appeared free from any visible damage.A functional inspection could not be performed (without deforming them) as the devices were firmly stuck together.Without dis-assembling the devices it is not possible to determine the exact root cause of the failure.This is the first reported case with this lot number.A review of the labeling did not indicate any abnormalities.If any further information is provided, the complaint report will be updated.

• Brand Name: TARGET DEVICE GAMMA3®
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• MDR Report Key: 9319380
• MDR Text Key: 191808211
• Report Number: 0009610622-2019-00921
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540716774
• UDI-Public: 04546540716774
• Combination Product (y/n): N
• PMA/PMN Number: K123401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2020

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 Model Number: 1320-0111
• Device Catalogue Number: 13200111
• Device Lot Number: KME912596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Initial Date Manufacturer Received: 10/16/2019
• Initial Date FDA Received: 11/13/2019
• Supplement Dates Manufacturer Received: 12/24/2019; 03/18/2020
• Supplement Dates FDA Received: 01/22/2020; 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1