MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X300MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 3325-0300S

Device Problems Break (1069); Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 03/31/2022

Event Type  Injury  

Event Description

It was reported that a gamma nail broke and the patient required revision surgery.

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.

Event Description

It was reported that a gamma nail broke and the patient required revision surgery.

Manufacturer Narrative

Please note corrections to h3, h6 method code, h6 results code and h6 conclusion codes.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 for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A device inspection was not possible since the affected device was thrown away and x-rays were provided in the communication chain but those belonging to the initial and first revision surgery were not related to the reported product or the reported event so no medical opinion was sought out.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on the provided information during the communication the nail broke due to pseudarthrosis, the root cause can be attributed to patient related.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X300MM X 125°
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14249928
• MDR Text Key: 290373267
• Report Number: 0009610622-2022-00158
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07613153313458
• UDI-Public: 07613153313458
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K200869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2023
• Device Model Number: 3325-0300S
• Device Catalogue Number: 33250300S
• Device Lot Number: K0694DF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/08/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention