MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3 10X320MM X 125; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3525-0320S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	05/15/2020
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 discarded.
Event or Problem Description
It was reported: a (b)(6) year old, male patient was discharged from the hospital one week after orif procedure with gamma nail on (b)(6) 2020.At that time, he was able to walk normally using crutches, and followed up with another hospital.However; on (b)(6) the patient was returned from another hospital to the hospital where he had surgery due to a possible nail breakage.He was very heavy ((b)(6)) and at the time of the initial surgery the surgeon attempted to wrap the femur with a cable, but it could not wrap well and there was no bone contact inside.So probably, all the nails were loaded and broke.Revision is scheduled on (b)(6).
Event or Problem Description
It was reported: a 45 year old, male patient was discharged from the hospital one week after orif procedure with gamma nail on (b)(6) 2020.At that time, he was able to walk normally using crutches, and followed up with another hospital.However; on (b)(6) the patient was returned from another hospital to the hospital where he had surgery due to a possible nail breakage.He was very heavy (106kg) and at the time of the initial surgery the surgeon attempted to wrap the femur with a cable, but it could not wrap well and there was no bone contact inside.So probably, all the nails were loaded and broke.Revision is scheduled on (b)(6).
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.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.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.The file will be closed formally in accordance to our procedures.In case the item and / or substantive information will become available in future the file will be reviewed and reopened.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3 10X320MM 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: 10144817
• Report Number: 0009610622-2020-00288
• Device Sequence Number: 3791869
• Product Code: HSB
• UDI-Device Identifier: 04546540375728
• UDI-Public: 04546540375728
• 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
• Report Date (Section B): 09/17/2020

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: 02/29/2024
• Device Model Number: 3525-0320S
• Device Catalogue Number: 35250320S
• Device Lot Number: K019E86
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/18/2020
• Supplement Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 06/11/2020
• Supplement Report FDA Received Date: 09/17/2020
• 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: 45 YR
• Patient Weight: 106