MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X300MM X 130°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	34300300S
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report; hospital policy.
Event or Problem Description
Right knee revision - patient had a static knee spacer, a gamma nail and cement.Spacer was removed and her knee reconstructed using a gmrs distal femur construct with an mrh tibial baseplate.
Additional Manufacturer Narrative
The reported event that long nail kit r1.5, ti, right gamma3® ø10x300mm x 130° was alleged of issue (revision) could not be confirmed, since the device was not returned for evaluation and no other evidences were 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.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.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The instructions for use provides below mentioned adverse effects which can lead to revision surgery - 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.Conditions attributable to non-union, osteoporosis, osteomalacia, diabetes, inhibited revascularization and poor bone formation can cause loosening, bending, cracking, fracture of the device or premature loss of rigid fixation with the bone.Improper alignment can cause a mal-union of the bone and/or bending, cracking or even breakage of the device.¿ if device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
Right knee revision - patient had a static knee spacer, a gamma nail and cement.Spacer was removed and her knee reconstructed using a gmrs distal femur construct with an mrh tibial baseplate.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X300MM X 130°
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 7827321
• Report Number: 0009610622-2018-01039
• Device Sequence Number: 2434030
• Product Code: HSB
• UDI-Device Identifier: 04546540375452
• UDI-Public: 04546540375452
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2018

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: 01/31/2022
• Device Catalogue Number: 34300300S
• Device Lot Number: K0D4A5D
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/02/2018
• Supplement Date Received by Manufacturer: 10/11/2018
• Initial Report FDA Received Date: 08/29/2018
• Supplement Report FDA Received Date: 11/09/2018
• 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: 61 YR