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

Model Number 1320-0111

Device Problem Mechanical Jam (2983)

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

Event Date 01/04/2022

Event Type  malfunction  

Event Description

As reported: "surgeon impacted nail with sleeve assembly instead of the strike plate.During insertion of the k-wire, the k-wire hit the nail and the k-wire could not be removed from the sleeve.At the end of the case, it was noticed that the nail holding bolt was stuck in the targeting arm.The impaction was done with the sleeves on the nail holding bolt.Another set was opened and replacement parts used.".

Manufacturer Narrative

Upon completion of the investigation, additional information will be provided in a supplemental report.

Manufacturer Narrative

Correction: please refer to d9/h3 - device not returned.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned, and no other evidence were provided for investigation.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: ¿during the procedure, repeatedly check that the connections between the instruments or between implants and instruments required for the precise positioning and fixing are secure.¿ more detailed information about the complaint event as well as the affected device must be available 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.H3 other text : device disposition is unknown.

Event Description

As reported: "surgeon impacted nail with sleeve assembly instead of the strike plate.During insertion of the k-wire, the k-wire hit the nail and the k-wire could not be removed from the sleeve.At the end of the case, it was noticed that the nail holding bolt was stuck in the targeting arm.The impaction was done with the sleeves on the nail holding bolt.Another set was opened and replacement parts used.".

• 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: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13388719
• MDR Text Key: 285676071
• Report Number: 0009610622-2022-00036
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540716774
• UDI-Public: 04546540716774
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2022
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2022
• 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