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

Catalog Number 13200111

Device Problem Failure to Align (2522)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/14/2021

Event Type  malfunction  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.

Event Description

As reported: "during a gamma surgery with a long gamma nail 130 degrees, the drill for the femoral neck screw could not be drilled through the nail.The drill always bumped against the nail.After some time, everything was dismantled and the femoral neck screw was implanted using the freehand technique.".

Event Description

As reported: "during a gamma surgery with a long gamma nail 130 degrees, the drill for the femoral neck screw could not be drilled through the nail.The drill always bumped against the nail.After some time, everything was dismantled and the femoral neck screw was implanted using the freehand technique.".

Manufacturer Narrative

Please note correction to section d4 lot number to unknown since the lot # provided does not match given cat#.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.A review of the device history was not possible because the provided sn [serial number] doesn¿t match given catalog # 13200111 in question.No corrective actions are required at this time.According to further details provided ¿the sales rep tested the target device with an implant and everything worked well.¿ and it could not be excluded that the reported event is rather related to a sub-optimal intraoperative procedure.However, the affected nail [implanted] in combination with the counterpart was not made available for evaluation and thus, an exact root cause could not be determined.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.

• 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; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12306777
• MDR Text Key: 265993981
• Report Number: 0009610622-2021-00635
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K123401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 13200111
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1