MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3 10X320MM X 120; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3520-0320S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Necrosis (1971)
Date of Event	03/03/2021
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.
Event or Problem Description
"it was reported that the patient's left femur was revised due to the patient progressing to avascular necrosis.A gamma3 nail construct was revised to a total hip.".
Additional Manufacturer Narrative
The alleged event, necrosis, could not be confirmed because no medical records were provided.The product in question was not returned but received images revealed the affected item being undamaged after approx.1.5 years of implantation.Review of device history, labelling, capa databases and risk analysis did not identify any discrepancies.There are no open actions in place related to the reported event for the subject product(s).No indications of material, manufacturing or design related problems were found during the document review.Avascular necrosis is known and nominated in the medical science / scientific literature.It is defined as the death of bone tissue due to a lack/ insufficient or interruption of the blood supply.Thus, the item is question is not linked to deficiency of the device but is related to the patient¿s condition.A product deficiency was not verified.In case essential information becomes available we reserve the right to re-reopen the case for investigation and to assess a new root cause.
Event or Problem Description
"it was reported that the patient's left femur was revised due to the patient progressing to avascular necrosis.A gamma3 nail construct was revised to a total hip.".

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3 10X320MM X 120
• 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: 11586389
• Report Number: 0009610622-2021-00434
• Device Sequence Number: 14191969
• Product Code: HSB
• UDI-Device Identifier: 04546540375599
• UDI-Public: 04546540375599
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2021

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/30/2019
• Device Model Number: 3520-0320S
• Device Catalogue Number: 35200320S
• Device Lot Number: K0518C3
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/03/2021
• Supplement Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 03/29/2021
• Supplement Report FDA Received Date: 06/16/2021
• 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: 70 YR
• Patient Weight: 91