MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, LEFT GAMMA3 11X300MM X 125; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 3325-0300S

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Injury (2348); Non-union Bone Fracture (2369)

Event Date 08/02/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported: "on (b)(6) 2020 suddenly turning on the right thigh when turning under full load.Radiological breakage of the gamma nail below the carrier screw.Clinically fatigue fracture of the material with inadequate bone healing.".

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, one of the probable causes of breakage could be fatigue fracture due to increased loading along with delayed union or non-union of the fracture site.If device is returned or any further information is provided, the investigation report will be reassessed.

Event Description

As reported: "on (b)(6)2020 suddenly turning on the right thigh when turning under full load.Radiological breakage of the gamma nail below the carrier screw.Clinically fatigue fracture of the material with inadequate bone healing.".

Manufacturer Narrative

Correction: refer to h6 method code.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.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.The instructions for use instructs user that: ¿adverse effects in many instances, adverse results may be clinically related rather than device related.The following are the most frequent adverse effects involving the use of internal fracture fixation devices: delayed union or non-union of the fracture site.These devices can break when subjected to the increased loading associated with delayed unions and/or non-unions.Internal fixation devices are load sharing devices which are intended to hold fractured bone surfaces in apposition to facilitate healing.If healing is delayed or does not occur, the appliance may eventually break due to metal fatigue.Loads on the device produced by load bearing and the patient¿s activity level will dictate the longevity of the device.¿ more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, one of the probable causes of breakage could be fatigue fracture due to increased loading along with delayed union or non-union of the fracture site.If device is returned or any further information is provided, the investigation report will be reassessed.

Event Description

As reported: "on (b)(6) 2020 suddenly turning on the right thigh when turning under full load.Radiological breakage of the gamma nail below the carrier screw.Clinically fatigue fracture of the material with inadequate bone healing.".

• Brand Name: LONG NAIL KIT R2.0, TI, LEFT GAMMA3 11X300MM 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
• MDR Report Key: 10479837
• MDR Text Key: 205274001
• Report Number: 0009610622-2020-00493
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07613153313458
• UDI-Public: 07613153313458
• Combination Product (y/n): N
• PMA/PMN Number: K034002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2023
• Device Model Number: 3325-0300S
• Device Catalogue Number: 33250300S
• Device Lot Number: K09CE74
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 57