MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3 11X340MM X 120; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3520-1340S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Necrosis (1971)
Date of Event	01/27/2021
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 avascular necrosis.Rep confirmed there are no allegations against the revised implants.A gamma nail, set screw, lag screw, and distal screw were revised.".
Event or Problem Description
"it was reported that the patient's left femur was revised due to avascular necrosis.Rep confirmed there are no allegations against the revised implants.A gamma nail, set screw, lag screw, and distal screw were revised.".
Additional Manufacturer Narrative
The reported event could be confirmed, although the product was not returned however images & revision usage sheet were provided that matches the alleged failure mode.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.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, based on the available information it¿s clear that the device was manufactured in 2012 and corelating it with the event date, root cause would be possibly due to but not limited to patient factor (poor bone quality, nonunion, activity and traumatic overload) rather than device related.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3 11X340MM 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: 11369166
• Report Number: 0009610622-2021-00290
• Device Sequence Number: 16377445
• Product Code: HSB
• UDI-Device Identifier: 07613252274124
• UDI-Public: 07613252274124
• 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 Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2021

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: 08/31/2017
• Device Model Number: 3520-1340S
• Device Catalogue Number: 35201340S
• Device Lot Number: K260587
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 04/01/2021
• 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: 71 YR
• Patient Weight: 73