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
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	08/02/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.".
Additional 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 or Problem 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.".
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 0009610622-2020-00493
• Device Sequence Number: 14232944
• Product Code: HSB
• UDI-Device Identifier: 07613153313458
• UDI-Public: 07613153313458
• Combination Product (Y/N): N
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 11/05/2020; 01/25/2021
• Initial Report FDA Received Date: 09/01/2020
• Supplement Report FDA Received Date: 12/02/2020; 02/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Weight: 57